Jobshttps://astellascareers.jobs2024-03-27T20:48:12-04:00(USA-IL-Northbrook) Project Manager, Clinical Development Operations2024-03-27T20:48:12-04:00https://astellascareers.jobs/B44A78277A494651B4B47A65EA4D5FA826Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Project Manager executes the identification and implementation of appropriate standards and consistent business processes, platforms, and analytics from relevant systems to facilitate alignment of related activities across DPM with the overall (Development Project Management) DPM and Development strategies; to enable DPM, and key stakeholders both within and outside the Development organization to take appropriate business actions and timely decision making.
Implementation of selected processes and other DPM initiatives in support of organizational efficiency and effectiveness.
**Essential Job Responsibilities:**
+ Displays a global mindset and fosters global optimization of DPM processes and systems.
+ Under the direction of the Team Lead, CPME, implements tools and processes to enable DPM’s global mission, & vision including the development of standardized PM tools and their application globally.
+ Provide expertise to integrate relevant global systems, including reporting and tools across PF/Development Division, collaborating with relevant departments, system owners, and other key stakeholders to progress oversight and planning.
+ Provide Primary Focus/Development Division support with asset level contracting requests & ECHO approvals in close collaboration with DPM and other key stakeholders.
+ Development and documentation of DPM best practices or further guidance detail of high level policies, SOPs or other guidance documents including drafting, reviewing, posting, distributing, and if necessary conducting roll-out training.
+ Manage activities for DPM (e.g., GPML Playbook , Training, Helix support, Monthly Report quality checks, task force support, DPM website/Sharepoint, contract/ECHO support, etc.)
+ May be asked to oversee / mentor junior staff or contractors.
+ Works globally with CPME and DPM members, oversees assigned task force activities, and works with process specialists within or outside DPM to achieve global functional objectives and deliverables.
+ Manages assigned terminated projects through full closeout in Helix and may also be assigned to support components of a larger, more complex 1project under the supervision of a Team Leader and guidance from other project management members.
+ Functions within relevant legislation and regulations.
**Quantitative Dimensions:**
Responsible to identify and implement appropriate systems and processes in DPM. Under supervision of the Team Lead, CPME or delegated mentor, manages the development and execution of assigned CPME activities in support of DPM. Additionally, the Associate Project Manager, CPME may contribute to divisional and corporate initiatives that relate to the drug development processes.
The Associate Project Manager, CPME helps to influence the acceleration of all projects globally. The span of control is approximately 10x larger than at project level. One successful project / year marketed a month sooner equals a month of peak sales, 10-100 okuYen (10-100 millions US dollar).
**Organizational Context:**
+ Reports to the Team Lead, CPME, who in turn reports to the Head, Operational Excellence, DPM.
+ Receives matrix leadership from DPM-LT when appropriate.
+ Gets assignments from Team Lead, CPME and works with the appropriate stakeholders to optimize the final roll out within agreed boundaries also agreed with the Team Lead, CPME (line manager).
**Qualifications:**
**Required**
+ Bachelor’s degree (follow up education in project management, e.g., PMI, IPMA, MCE, PRINCE2, etc. is a plus).
+ 2+ years in PM and/or pharmaceutical R&D experience
+ Proficient and adaptive in utilizing, manipulating and creating outputs using relevant software.
+ Experience in processing contracts and collaborating with key stakeholders, is preferred.
+ Demonstrated communication, negotiation/influencing, and social skills with a sense of diplomacy, relating to peers, as well as higher management. Leading and attending meetings, presenting and training in English.
+ Demonstrated ability to proactively recognize process/system improvements and innovation opportunities, and work with appropriate stakeholders to develop solutions.
+ Works effectively under pressure, accurate and patient, team-oriented.
+ Self-organization skills and inclined to set clear priorities on meeting targets with affinity with financial reporting and planning systems.
+ Thorough insight in general PM context / processes/ procedures, and their application
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category ONC DPM
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-SC-Florence) Clinical Sales Professional, Community Specialties - Myrtle Beach, SC2024-03-27T20:48:10-04:00https://astellascareers.jobs/7B150E73C2684A3DBDE6B82FD188D8E626**Clinical Sales Professional, Community Specialties – Myrtle Beach, SC**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Myrtle Beach, SC** area.
**The Role:**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset.
**Primary Responsibilities:**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations.
+ Execute company-approved Product Marketing plans and territory/regional business plan activities.
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management.
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines.
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations.
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports.
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager.
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed.
**Quantitative Dimensions:**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics.
**Organizational Context:**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position.
+ Reports to Regional Sales manager.
+ Maintains territory responsible for managing Astellas' products.
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate.
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance.
+ Exhibits strong level of skill in competencies.
+ Demonstrates sales influence within territory and at times within region.
**Qualifications**
**Required:**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred:**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position.
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) Clinical Development Scientist Lead, Immuno-Oncology2024-03-27T20:48:10-04:00https://astellascareers.jobs/FCD454FBFB554C0EB523053F9E1B506726At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope:**
The primary purpose of the Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, and Asset Lead, and Medical Monitor, and is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.
**Essential Job Duties:**
+ Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
+ Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
+ Serves on the clinical sub-team with GML, Operations Lead, and Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
+ Under the guidance of study physician/med lead, perform medical monitoring activities (Review, analyze and triage patient data, generating reports
+ Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
+ Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
+ Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
+ Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
+ Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
+ Early and/or late phase studies
+ Exhibits expertise related to Study Data Review and Analysis:
+ Provides clinical input into statistical planning, data analysis and interpretation
+ Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
+ Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
+ May lead the execution of contracts, particularly for investigator meetings and advisories.
+ Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
+ Serve as key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape and clinical characteristics.
+ May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
+ Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
+ Performs other duties as assigned or special projects as needed.
+ This position reports to the Primary Focus Medical Head (or other Leads depending on grade) for designated program.
+ This position is typically an individual contributor role, but may have direct reports based on scope, accountabilities and complexity of assigned development programs. If position has direct reports, will align with Astellas guidelines for span of control and organizational levels.
**Required Qualifications:**
+ Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 9-10 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry.
+ Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
+ Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
+ Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
+ Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
+ Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
+ Knowledge of global pharmacovigilance standards and guidance documents.
+ Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
+ Excellent strategic planning, organizational and verbal and written communication skills.
+ Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions. Highest level of scientific integrity.
+ Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
+ Able to travel ~25%, with international travel at times
**Preferred Qualifications:**
+ PhD. or PharmD degree, or other relevant Master’s degree.
+ Knowledge and proficiency related to Medical Affairs activities including registries.
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
Category Therapeutica Area - Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Scientist II, Immuno-Oncology2024-03-22T20:48:12-04:00https://astellascareers.jobs/9B895E6632E2463BBAA9C54E3DA590DD26**Scientist II, Immuno-Oncology**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Scientist II, Immuno-Oncology** opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
**Purpose:**
We are seeking a highly motivated and talented Scientist to join our R&D team and play a key role in developing a human pluripotent stem cell (PSC)-derived CAR cell therapy for clinical applications. The successful candidate will have a track record of success in a collaborative research environment with proficiency in oncology animal models, various standard immunology and cell biology techniques and a proven ability to plan and execute experiments and analyze data independently. The Scientist will apply their knowledge of immuno-oncology towards the generation of an exciting cell therapy opportunity.
**Essential Job Responsibilities:**
+ Performs research and/or development in collaboration with others.
+ Makes detailed observations, analyzes data and interprets results.
+ Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project goals.
+ Prepares technical reports, summaries, protocols, and quantitative analyses.
+ Contributes to project process within his/her scientific discipline.
+ Investigates, creates and develops new methods and technologies for project advancement.
+ Maintains high level of professional expertise through familiarity with scientific literature.
+ Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
+ Initiate and coordinate in vivo solid tumor models.
**Quantitative Dimensions:**
+ Ability to independently and efficiently perform laboratory experiments.
+ Demonstrates clear conceptual understanding of project goals, experimental design, data analysis and troubleshooting.
+ Excellent communication and interpersonal skills.
+ Demonstrates effective collaboration with team members and other teams.
**Organizational Context:**
+ Communicates with other members of multidisciplinary teams.
**Qualifications**
**Required:**
+ Education: BS with 10+, MS with 7+, or Ph.D. with 3+ years laboratory experience.
+ Hands-on experience with animal models of solid tumors including s.c. and i.p. implantation.
+ Demonstrated industry experience or academic achievement, e.g., strong publication record or drug development portfolio.
+ Experience with immune cell characterization and profiling using flow cytometry, immunofluorescence, and cell isolation techniques.
+ Excellent written and oral communication skills.
+ Expertise handling animals and performing IV, SC, and IP injections.
**Preferred:**
+ Experience with the CT26 tumor model or other immunocompetent animal studies.
+ Demonstrated ability to perform BLI measurements of luciferase+ tumors.
+ Hands on experience with in vivo analysis of TME factors, tumor development, and immune cell trafficking.
+ Familiarity with lentiviral transduction of immune cells.
+ Experience with human or mouse PSC manipulation is welcome but not required.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
*LI-TD
Category IRM-Research
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-NJ-Jersey City) Lead, Ophthalmics BU Operations and Planning2024-03-22T16:49:34-04:00https://astellascareers.jobs/8E63C4FF2D7344919E14C48CB1A4F07326Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Parsippany, NJ. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
A strategic partner to the Chief Commercial Officer (CCO) and the Ophthalmics BU Leadership Team who helps manage the team’s priorities, provide organization and tracking across multiple work streams, and provide project management for assigned initiatives. This role recommends processes and procedures to create efficient operations across the commercial organization by facilitating the implementation of our BU vision and the execution of our commercial strategies. This role requires a leader with an exceptional level of organization, project management and communication skills. In addition, this role requires an in-depth understanding of the different commercial and enterprise functions and their interdependencies.
**Essential Job Responsibilities:**
+ Acts as an advisor to the CCO and the leadership team and provides thought partnership on key initiatives.
+ Assesses and creates recommendations for commercial operations efficiency and leads initiatives for continuous improvement related to business operations, including establishing best practices.
+ Serves as the primary organizer and owner for key team meetings.
+ Track and communicate the overall commercial performance results.
+ Create and support the development of presentations for CCO across a range of topics including, internal business updates, Town Halls, and external presentations, as needed.
+ Partner with Communications lead to plan key commercial team communication events.
+ Work with the leadership team to design and execute cultural initiatives and events to bring colleagues together, share priorities, celebrate success, and reinforce our leadership commitments.
+ Partner with Finance and the leadership team for budget planning and tracking.
+ Contributes to our compliance minded culture and supports the team to consistently operate in a compliant manner.
**Qualifications**
**Required:**
+ Bachelor’s Degree in science or business-related discipline; MBA preferred
+ 10+ years of experience within the pharmaceutical or biotechnology industries
+ Previous experience in a commercial Marketing, Strategy or Operations role preferred.
+ Broad range of leadership competencies and ability to work in cross-functional role
+ Excellent organizational, communication, and presentation skills.
+ Role model for our leadership commitments
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category United States Commercial
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Biosample Operations Manager2024-03-22T16:49:33-04:00https://astellascareers.jobs/71336FB12C70426B8870C43D219F3C9C26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois or Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The purpose of this position is to plan, initiate and execute Biosample management activities. The position includes vendor management, training and effective interactions with study teams, process development and improvement, Biosample management system administration and sample tracking activities. Responsibilities to be performed independently with minimal guidance by supervisor.
**Essential Job Responsibilities:**
The Biosample Operations Manager (BOM) is responsible for all operational activities associated with the implementation and maintenance of studies in the sample management system and to act as a resource for best practices for biosample management.
The following key activities are the Sample Management responsibilities of the BOM:
**Sample Management System:**
+ Manage and coordinate study set up in Sample Management system
+ Act as liaison between study team, Sample Management vendor and Biosample vendors
+ Monitor study build and rollout according to timelines.
+ Ensure system training is conducted and support study team usage.
+ Contribute to ongoing team forum by providing feedback on lessons learned, discuss challenges and changes etc.
+ Collect and maintain completed lessons learned and evaluation documents for consolidated review
**Process Development, Improvement and Maintenance:**
+ Support the maintenance of any associated quality documents relative to Biosample management to ensure they are kept current and accurate.
+ Support the maintenance of the Biosample Operations Work Instructions and Templates.
+ Participate in vendor evaluation as required (e.g., new technologies, clinical CRO selection).
+ Contribute to various Medical & Development process improvement initiatives and SOP (or other quality document) development.
**Training and Communication:**
+ Identify any training needs and participate in the development of any sustainable training materials required.
+ Support the ongoing review of training materials to ensure they are current, accurately reflect the appropriate BSMO processes and are appropriately deployed to the affected departments and job functions.
+ Maintain the BSMO SharePoint site.
**Quantitative Dimensions:**
Studies are to be planned and initiated in the sample management system with minimal guidance in accordance with agreed upon timelines and using effective vendor management strategies. Manager will be responsible for oversight and support of study teams for Sample Management activities as well as participation in ongoing development of the Astellas best practices in sample management.
**Organizational Context:**
Reports to Biosample Operations Lead, Early Development Clinical Operations or above.
**Qualifications:**
**Required**
+ Bachelor's degree (or equivalent) with scientific or clinical background, study management experience preferred
+ 2 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 1 years’ experience as clinical study manager, central laboratory project manager, data manager, or project manager.
+ Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents
+ Experience with protocol and clinical drug development processes
+ Proven project management skills and leadership ability
+ Excellent interpersonal, written, and verbal communication skills and computer ability
+ Fluent in English
+ Moderate travel is possible
**Preferred**
+ Experience with Biosample Tracking/Management preferred.
+ Ability to integrate and apply GCP, clinical operations, and scientific knowledge in the planning, management, data review, and reporting (as applicable) of Biosample related data.
+ Ability to read and understand clinical protocols and related documents, especially with regard to collection, processing, storage, and shipment of critical specimens (e.g., PK, PD, Biomarker, PGx, etc.) in accordance with the protocol, clinical operations manual, and laboratory manuals
+ Problem solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of region-appropriate GCP regulations and guidance, Astellas SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).
+ Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).
+ Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.
+ Competent presentation skills (i.e., verbal and visual presentations are logical, organized, accurate and understandable.)
+ Excellent writing skills (i.e., concise, accurate, unambiguous style without typos and grammatical errors.)
+ Excellent oral communication skills (i.e., can describe experiences and issues clearly and concisely and then if necessary, provide details.)
+ Highly Organized (i.e., Aware of status of tasks/milestones of assigned projects and of delegated tasks)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution (RRSP for Canada)
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Early Development Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Head, US Commercial Finance2024-03-22T14:48:25-04:00https://astellascareers.jobs/4EF1FDC1C7514F99BC04ADC504A963FE26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Commercial Finance US Lead has overall accountability for Commercial Finance across the Commercial Operations organization in the US region. This role will be required to develop the relationship with Global leaders, driving credibility through deep financial expertise and insight, providing the necessary challenge to pursue the interests of the organization, and support the global strategy. Ideal candidate will be responsible for providing strategic financial support to the global Head of Commercial Finance and to the President Commercial Operations of US, in order to optimize short-term and long-term operating results, balancing strategic priorities across Commercial Finance.
Lead a team who will collectively partner with the commercial business to drive performance across the US. This team governs the preparation and analysis of financial results and provide financial insight to the business to drive informed decision making and value creation across the region short to long-term. This role is a key ambassador in ensuring that activities are optimized and standardized across the region.
This role will be required to proactively formulate the regional commercial strategy and initiatives, challenging and influencing global stakeholders and the Management Team to safeguard the assets of the business. They will ensure that optimal resource allocation decisions are made.
**Essential Job Responsibilities:**
1. **Leadership:**
+ Shape and evolve the ways of working with the business to optimize the value delivered by the Commercial Finance team.
+ Provide financial leadership, relevant insight and challenge in determining and delivering the strategic Business direction (e.g. pricing/Gross to Net, portfolio & resource decisions, improving margin).
+ Stimulate behaviors and alignment across the organization, supporting the delivery of the business strategy.
+ Lead and motivate the Commercial Finance department, building an effective team of direct reports who can effectively develop and drive the commercial finance strategy in the Market.
1. **Investments:**
+ Evaluation of investment proposals and formulation of recommendations for the approval of senior management.
+ Act as a catalyst in moving forward initiatives critical to delivering the market strategy and results.
+ Assess commercial viability and ROI of investment decisions.
+ Articulate financial risks and opportunities and drive post-investment appraisal of business initiatives.
+ Develop tools and solutions to maximize financial return on investments across the Region.
1. **Planning and Budgeting:**
+ Accountable for implementing the planning processes in the market in alignment with the global process and influencing the global process to work effectively within the market.
+ Driving forward the financial forecasting process, and effectively managing risks and opportunities, allowing opportunities for the business to create value through adjustments and reallocations of investments.
+ Lead the budgeting process, including target setting, challenging the market and finalization of stretched but achievable targets
+ Bring enterprise thinking to the market, to challenge the plans / results as well as bringing market insights to the above-market team to support effective enterprise decisions.
+ Support effective business performance management, including setting appropriate KPIs, reporting and challenging the business to improve results, grow profits and create sustainable value.
+ Leverage business knowledge and relationships to effectively support and challenge business performance and Planning, Budgeting & Forecasting.
1. **Compliance:**
+ Embed Compliance Culture across all markets of the Region ensuring Integrity in Action is actively applied in all initiatives and proactively address non-compliance.
+ Ensure adherence to Astellas policies relating to healthcare compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).
+ Ensure adherence to Astellas policies relating to Finance Controls and Compliance standards.
+ Ensure a culture of Ethics and Compliance; lead by example and incorporate cross-cultural perspectives when addressing challenging situations.
1. **Other:**
+ Promote operational culture within the region, continuously improving processes and ways of working across the region and in alignment with API and RHQ.
+ Build and lead strong, effective teams of highly capable professionals, focusing on development of commercial finance capability across the Region.
+ Other such duties as may be reasonably required by the business.
**Quantitative Dimensions:**
+ Financial: Responsible for US sales of approximately 6B USD and the budget of Commercial Operations to achieve these sales;
+ People: 3-4 direct reports and working in partnership with an FPA COE team.
**Qualifications**
**Required:**
+ Qualified accountant (ACA, ACCA and CIMA) degree or MBA.
+ A minimum of 12 years focused on internal controls/ financial governance with a multinational Astellas and/or a Big 4 firm
+ Experience managing on a regional basis
+ Demonstrated track record of supervising, mentoring and motivating talent.
+ Knowledge of IFRS and JSOX requirements
+ Substantial experience in Executive leadership role in Pharma sector with strong patient/customer focus, in multi-disciplinary, matrix and global context.
+ Evidence of devising and implementing regional strategy within pharma sector and achieving exceptional results.
+ Proven understanding of industry and regulatory requirements (codes, standards, regulatory and legal) for Pharma sector and evidence of embedding a culture of Healthcare Compliance across geography/region.
+ Must have operated internationally – experience working remotely with Japan/Asia also beneficial.
+ Evidence of developing diverse and high potential teams and talent management.
+ Ambassador for change with proven track record leading major cultural and organizational change initiatives.
+ Politically astute with sound judgement. Collaborative by nature and able to challenge respectively and constructively.
+ Fluent in oral/written verbal business English – ideally with a second European language.
+ Excellent organizational and problem-solving skills
+ Strong commercial acumen
+ Impactful, credible with senior stakeholders internally and externally.
+ Ability to effectively influence both internal and external stakeholders.
+ IT literate.
+ Ability to manage several projects and matters simultaneously under demanding time pressures from both Japan and RHQ.
+ Ability to operate effectively within an international business environment and deal with people from various cultures.
+ Based in a close location to the Leadership Team of US
+ Ability to travel.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual Astellas contribution
+ Astellas paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category Commercial Finance
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Associate Director HEOR - Real World Evidence (Oncology)2024-03-21T09:45:27-04:00https://astellascareers.jobs/FE93E3C9745641FF89A2E27A59DAFD5A26**Global Associate Director, HEOR RWE**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
+ Responsible for pro-actively formulating, consolidating, and implementing Astellas HEOR strategies and ensuring that HEOR perspectives and strategies across geographies are integrated within the MA core medical plans; integrated global value plans, evidence generation plans, brand plans; launch excellence plans and relevant development plans. Represents consolidated HEOR voice in cross-functional teams (e.g. GPST, CMT)
+ Responsible for development, management and delivery of core health economic, comparative effectiveness, patient reported outcomes, and epidemiologic data, real world evidence, and budget impact and cost effectiveness analyses and modeling; for overseeing health technology assessment including early scientific advice and assessments post-approval for assigned inline and early (ESMA) and late-stage development compounds that are medically relevant and scientifically and technically valid, address business needs and support patient access and HTA/reimbursement requirements
+ This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
**Essential Job Responsibilities:**
**Medical Affairs Leadership**
+ Co-lead development of integrated global value plan, co-create integrated global brand plan and integrated Evidence Generation Plan
+ Responsible to develop HEOR strategies and tactics that are evidence based, scientifically and technically valid, and medically relevant; of clinical, humanistic, and economical importance; patient focused; are integrated in the Core Medical Plans and address the needs of regulators, HTA, payers, patients, health care providers, and policy makers and regulators across geographies and in line with global brand plan and global value plan, including strategy development for pre-POC early development compounds in ESMA
+ Responsible for successful execution of all MA HEOR activities and deliverables for assigned product across geographies and to ensure these are delivered with high quality and within timelines and budget
+ Accountable for the development and maintenance of core value dossiers and core economic models that provide the foundation for region and affiliate HEOR professionals to create local value dossiers and local economic models to fulfill local HTA/reimbursement needs across assigned products
+ Leads PRO strategy development and early value assessment for ESMA
+ Support regional / local adaptation of core value dossiers and core economic models to local HTA requirements and oversee alignment with the global value messages
**Departmental and People Leadership**
+ Serve on organizational initiatives and taskforces as appropriate to shape the strategic direction of the HEOR function
**Matrix Leadership**
+ Lead global value team and core health economics team
+ Represents HEOR function in cross functional teams such as core team, GPST, CMT, ESMA team and ensures strategic needs and perspectives across geographies are represented
+ Leads HEOR interaction with Development for ESMA products
+ Maintains an integrated partnership within Medical Affairs and cross-functional colleagues including global Market Access to identify collaborative opportunities, ensure optimal alignment, leverage resources, and support business priorities
+ Actively promote strategic collaborations with other Astellas HEOR colleagues across the globe to share and replicate best practices and advance HEOR initiatives to support the Astellas product portfolio and patient access.
**Scientific / HEOR technical Expertise**
+ Maintains in depth knowledge of Astellas products/disease states for assigned products
+ Provide strategic consultation to preparation and coordination for HTA/payer advice, mock preparations, submissions, face to face meetings and objection handling Actively monitor the changing healthcare landscape to identify emerging clinical and health economic trends
+ Maintain in depth knowledge about patient access and HTA/reimbursement requirements, processes and best practices to inform HEOR strategies.
+ Represent Astellas on HEOR issues at global forums, conferences and professional associations; including monitoring ad communicating activities by such forums to executive leadership
**Medical Governance**
+ Provide oversight and strategic and scientific input for HEOR projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent research proposals for assigned products
+ Ensure the timely completion of assigned HEOR projects that include appropriate outcome assessments, analysis plans and final reports with expectations for peer-reviewed publications relevant to HEOR evidence generation strategies
+ Ensures all HEOR deliverables support Astellas’ commitment to integrity and delivery of the highest standard of quality and in compliance with all applicable regulations, external policies and ethical standards
**Quantitative Dimensions:**
The HEOR Global Product Lead develops innovative, cutting edge economic, epidemiological and clinical outcomes data generation activities and related medical tools (>15 annually) across assigned products that are designed to shape the medical value proposition for Astellas products throughout their life cycle including early development compounds. The HEOR Global Product Lead will provide matrix leadership to represent regional and local HEOR within the GVT, CMT, GPST and iEGP teams. He/she is accountable for managing resources, priorities and workload across products and includes direct budget responsibilities of $1-1.5 mln annually. The results produced by the HEOR Global Product Lead must be scientifically sound and in compliance with applicable regulations
**Organizational Context**
The HEOR Global Product Lead reports to the Global HEOR TA Lead. They will have multiple
cross-functional collaborative project teams and matrix responsibility across the broader Astellas
organization.
The HEOR Global Product Lead will collaborate with the following colleagues:
+ Medical Affairs: TA Heads, Executive Directors, CMT leads, ESMA leads, Senior Medical Directors/CMT members, HEOR Leaders
+ Development: Global Development Project Leads, Core Team Leads, iEGP Leads, Core/Project Team members, Global Medical Leads
+ Commercial and Market Access: Strategic Brand Managers/GSPT co-leads, Market Access Leads
+ Other: Senior Director/Director Legal, Ethics & Compliance, Brand General Managers
+ External: Executive leadership of Astellas partners and organizations
**Qualifications**
**Required**
+ Advanced Degree (PharmD, PhD, MD) with consideration for MPH or other advanced degree in Life Sciences, HE or Epidemiology with relevant advanced industry experience
+ 3-5 years relevant experience in at least one of the following fields: Outcomes Research, HE, Clinical Research, Epidemiology, Health Policy
+ Demonstrated strategic thinking, problem solving and decision making skills
+ Expertise in understanding interface between clinical practice and outcomes research
+ Expertise in leveraging outcomes data in the appropriate clinical context
+ Demonstrated strong interpersonal relationship and collaboration skills working within cross[1]functional teams
+ Thorough understanding of global guidelines as they relate to HEOR and Medical Affairs
+ Expertise in global HTA/payer reimbursement and market access requirements
+ A collaborative style of working and a strong sense of ethics, compliance and integrity
+ Excellent written and verbal communication and presentation skills
+ Expertise in HEOR including principles, pharmaceutical research design and methods as well as excellent project and vendor management skills
**Benefits**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
*LI-CH1
Category HEOR
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-FL-Fort Lauderdale) Clinical Sales Professional, Community Specialties – Hollywood South, FL2024-03-19T20:48:14-04:00https://astellascareers.jobs/C47A9EDB8A714A54B6A8D5EEB1C8E39226**Clinical Sales Professional, Community Specialties – Hollywood South, FL**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Hollywood South, FL** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Senior Manager/Associate Director, Pharmacovigilance Quality Assurance2024-03-19T16:49:31-04:00https://astellascareers.jobs/EF05D51302FA4D6CBC929E1F662310EC26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in United States or Canada. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The primary focus of this position is to contract and manage resources responsible for assessing processes at Astellas, and any contracted service providers to ensure that systems, policies and procedures comply with national and international requirements for the pharmacovigilance function and the collection and reporting of safety information.
This comprises both auditing as directed, and consultancy activities and related control of cost and financial aspects. This role develops and manages a sub selection of the quality system and operations across region.
As QA Expert, provides QA consultancy (Identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow up of Regulatory Inspections as directed.
**Essential Job Responsibilities:**
+ Execution of regional, cross regional and/or global multiple audit programs. This includes the planning, conducting and reporting of audits, liaising with customers on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for Astellas organization continuous improvement. Lead the proper management and follow up of the findings and improvement areas.
+ Provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to :
+ Reviewing of the responses/communication provided to health authorities ( e.g. in case of inspection)
+ Interpreting health authorities requirements and advising in their implementation across Astellas organization
+ Responsible for preparation of the different Astellas entities and or partners to any regulatory inspection. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program across the departments and the territories ensuring harmonized approach.
+ Work with the PVQA leadership in identifying needs for outsourcing, selecting, managing and evaluating 3rd Party QA service providers to which audit and/or consultancy activities are being outsourced. This includes managing financial information and maintaining effective interfaces to ensure that output meets defined expectations in terms of content and timelines.
+ Support the development, improvement and maintenance of the Astellas Quality System by signaling root causes to non-conformances related to the system, by addressing observed gaps in the system.
+ Manage Quality Issues related to critical non-conformities, serious misconduct and potential fraud. Lead proper corrective and preventive actions identification and roll out and ensure follow up with effectiveness measures.
+ Develop, analyze and report relevant key performance indicator information.
+ Manage GxP inspections. This includes communication with Regulatory authorities, Inspection preparation, hosting, support of CAPA generation and monitoring of follow up to ensure that any risk / non-conformance as identified by inspectors is adequately addressed and mitigated.
+ Develop and manage interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to Astellas business is being mitigated.
**Quantitative Dimensions:**
+ Managing audit programs which approximately contain between 15-30 Audits annually, depending on complexity.
+ Approximately 50% of time is spent in the audit role and an equal amount in the consultancy role and other QA related activities.
+ Frequent national and international travel (up to 25%).
+ Contribute to the management of the financial information on outsourced audits for individual audits involving the use of contract auditors. .
+ Frequent Presentations on GPvP, Audit Results and Process Improvement on average once per month.
+ Frequent, monthly PVQA Departmental Meeting with direct QA colleagues
**Organizational Context:**
+ Reports to the Director PVQA
+ Frequent contacts with R&D departments VPs and delegates: clinical operations, Data Sciences, Pharmacovigilance, Clinical Pharmacology, Bioanalysis, Medical Affairs, IT, IGD, Regulatory Affairs.
+ Frequent contacts with CRQA departments (Clinical QA, Quality Operations, Research QA).
+ Auditees: CROs/vendors/service providers (senior management, project management, QA, functional team personnel, license/business partner personnel, in addition to internal Astellas staff.
+ Represents PVQA on and contributes to M&D- and/or CRQA projects as assigned.
**Qualifications:**
**Required**
+ Bachelor’s degree; Advanced degree preferred.
+ Seven (7) years’ experience in clinical/Pharmacovigilance QA, or in the pharmacovigilance function.
+ Excellent knowledge of QA Standards, particularly Good Clinical and or GPvP Practice Guidelines and Regulations and other related areas as specific for the function (e.g. PV), as well as basic legal regulations.
+ Very good interpersonal and communication skills.
+ Ability to influence without authority.
+ Project Management Skill.
+ Excellent attention to details.
+ Flexibility and Adaptability .
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution (RRSP for Canada)
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Clinical & PV QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) Senior Medical Manager Specialties2024-03-19T09:45:29-04:00https://astellascareers.jobs/943A60015DD843BEBD0BCDDE9FA9E1D526**Astellas Canada - Senior Medical Manager, Specialties**
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
Astellas Pharma Canada is currently searching for a Medical Manager reporting to the Therapeutic Lead, Specialty. This is head office position located in Markham, Ontario.
**Description**
The Medical Manager is responsible for the implementation of the medical strategy (Core Medical Plan, “CMP”) with a focus in Women’s Health at the affiliate level by coordinating and executing medical / scientific activities to (i) understand the local external environment and data gaps; (ii) translate insights into strategies and activities and (iii) ensure the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use of Astellas products.
Specifically, this individual will:
+ Provide strategic medical and scientific expertise in support of all affiliate Medical Affairs (MA) deliverables and cross-functional activities
+ Demonstrate leadership by developing and maintaining integrated partnerships with key internal and external stakeholders to ensure all MA affiliate activities address local needs and advance the medical/scientific understanding of Astellas products across their lifecycle
+ Responsible for understanding and engage external stakeholders to advance the science behind compounds in development, the safe and effective use of Astellas products and disease states that they treat.
+ Responsible for engaging and collaborating with key internal stakeholders, including the brand teams across the affiliate to achieve local business objectives
+ Ensures all affiliate MA activities deliver value and are based on scientific validity, clinical importance and on time and budget.
**Essential Job Duties**
**Understand External Environment and Data Gaps**
Scientific Intelligence
+ Demonstrate thorough understanding of the therapeutic area (TA), unmet needs and future developments
+ Engage external stakeholders (such as health care providers, payers and decision makers) and gather as well as share competitive scientific intelligence
+ Develop and maintain in depth scientific and medical expertise of assigned TA through self-study, company-provided training and scientific meeting attendance
Advisory Boards
+ Conduct advisory boards as needed per the life cycle of the product to seek expert advice, opinions and feedback from advisors on medical, humanistic, health economic or clinical topics related to marketed or development-stage compounds to inform MA and commercial strategies, plans
Medical Insights
+ Collaborates cross functionally with internal stakeholders to support communication of relevant scientific and medical insights
+ Oversee medical insights generation activities and incorporate actionable insights into the strategic planning processes in collaboration with operational excellence and regional TA leads
**Translate Insights into Strategies and Activities**
Core Medical Plans
+ Identify the unmet needs and develop medical strategy to incorporate in the CMP as well ensure a compliant execution of all Affiliate Medical/Scientific activities i.e., launch activities, educational programs, advisory / expert meetings, symposia in congresses
+ Ensure the affiliate CMP is aligned with Global CMP, Integrated global brand plan, and local brand strategies
+ Strategically leverage regional and global medical initiatives to meet local business needs, while maintaining an enterprise view
+ Implement the affiliate CMP tactics for the TA, on time and on budget as well as update CMP trackers on time
Collaboration Within M&D
+ Provide reactive support to development team to identify potential study investigators / sites and assist with feasibility study execution
+ Provide scientific/medical support to regulatory affairs on submission of dossiers and presentations upon request
+ Provide scientific/medical support to regional clinical operations and/or pharmacovigilance teams in execution of mandatory post-approval studies,
+ Partner with Regional Operational Excellence team to provide regular input to monthly reports for the General Manager/Regional President/Chief Medical Officer
Collaboration with Commercial
+ Provide strategic scientific/medical expertise to Marketing, Market Access, Business Intelligence, Sales in support of all cross-functional activities (advice, reports, recommendations, etc.).
+ Champion a collaborative mindset to ensure full alignment with key stakeholders’ cross-functionally
+ Review and approve promotional materials complying with local and applicable internal/external regulations and/or policies.
+ Coordinate in executing medical-scientific activities in product launches: disease area presentations, expert meetings.
+ Participating as a therapeutic area/product expert in internal company meetings and provide medical-scientific support for external meetings in a fair and balanced manner (post-approval symposia)
+ Provide training on therapeutic area and products to the colleagues (including commercial) in the affiliate
**Fulfill Information Needs of External Stakeholders**
Data Generation for HCPs and Payers
+ Partner with the Health Economics and Outcomes Research (HEOR) and Market Access to provide insight on local access strategies and challenges and close data gaps
+ Plan and develop HEOR data generation projects, not limited to Budget Impact Model/ Cost-effectiveness analysis
+ Partner with market access in reimbursement or listing discussions with payers/hospitals as needed
Data Communication and Medical Education
+ Provide medical / scientific education and training to internal stakeholders on marketed products and compounds in development
+ Acts as local scientific expert to regional Medical Information group (i.e., escalated inquiries), ensuring all local regulatory requirements are met and in compliance with Astellas procedures and ethical standards.
+ Strategically manage the development of local Non-Promotional Medical Materials in alignment with TA/ affiliate objectives, including, but not limited to slide presentations and posters / manuscripts
+ Identify and engage key external experts (KEEs) in in-depth medical product or disease area scientific exchange, and presentations to communicate the value of Astellas products in a fair and balanced way in accordance with Astellas values/code of conduct and local regulations
+ Develop, maintain, engage with (KEEs), HCPs, healthcare organizations funding bodies and other entities communicate the value of Astellas products in a fair and balanced way accordance with Astellas values/code of conduct as well as applicable local regulations
External Program Funding for Research and Education
+ Support the affiliate head and regional reviewers in reviewing as well as appropriate documentation of Investigator Sponsored Research/ Grants for general research/ Grants for Medical Education/ Sponsorship for Research & Education
+ Obtain post-activity evidence, including documentation and financial reconciliation
**Compliance & Governance**
+ Ensures all affiliate MA activities are in compliance with all applicable Astellas policies, external regulations and ethical standards
+ Partners with Ethics & Compliance to review commercial led promotional tactics and inputs to ensure adherence to compliance in all areas of operations.
**Field Medical Activities**
+ An office-based hybrid professional Medical Affairs leader responsible for identifying, accessing and effectively engaging with key external experts to foster scientific exchange and mutually beneficial collaboration.
**Required Qualifications**
+ Doctoral degree (MD, PhD in health-related science or PharmD)
+ Minimum 4 years’ experience in Pharma.
+ 3-5 years’ experience in Medical Affairs
+ Suitable candidates from academia with strong expertise in the therapeutic area including clinical/ hospital practice, clinical development, experience in designing, executing and reporting of clinical trials can be considered.
+ Strong understanding and knowledge of industry laws and regulations.
+ Experienced in managing complex projects and effectively act independently (ex. Ad Boards, Publications).
+ Demonstration of ability to effectively interact in a matrix organization with matrix reporting lines.
+ Proactive strategic partnering with different internal functions (ex. Commercial, Market Access, HEOR.)
+ Excellent presentation skills and advanced written and verbal business English.
+ Foundational understanding of the drug development and commercialization process. Ability to travel 20-30% of the time including overnight travel
**Preferred Qualifications**
+ **** Contributing to / supporting onboarding and development activities for colleagues e.g., acting as a buddy, mentor or coach
+ Demonstration of delegated responsibilities successfully completed e.g., acting as a backup for a Therapy Area Lead at key internal or external meetings.
****
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
*LI-CH1
Category Medical Affairs - Established Markets
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Senior Project Manager, MA US2024-03-18T20:48:13-04:00https://astellascareers.jobs/F547663123F64A51818E0784E05EE74D26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
Accountable for leading and delivering Project Management activities for assigned products, Core Medical Teams, Core Medical Plans, Product Strategy Teams (Global / Regional) and integrated plans. Works in partnership with the relevant TA Head(s) and Core Medical Team Leaders. Provides strategic direction and oversight in ensuring execution and delivery of MA tactics and Launch Excellence activities on time and within budget. Develops new processes and improve existing processes within the organization and governance model.
**Essential Job Responsibilities:**
Medical Affairs Leadership
+ Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the CMT Lead in the delivery of the CMP and all CMT activities. Same responsibilities for the Global Product Strategy Team working with the GPSTs co-leads (Medical Affairs and Marketing Strategy) and chair. Monitors, tracks and reports timelines, budgets, resource and risks related to all CMT and GPST activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Provides Launch Excellence project management expertise on the tools, planning, processes, and execution oversight.
+ For assigned products, lead the execution of the annual Core Medical Plan (CMP) and annual budget process for compounds, including quarterly forecasting and proactively manage and communicate budget and budget variance to the PM Forum and senior leadership. Same responsibilities for the Global Product Strategy Team and iGBP working with the GPSTs co-leads (Medical Affairs and Marketing Strategy).
+ Collaboration with other medical affairs colleagues in budget planning, forecast review and management in collaboration with M&D finance. Member of team for quarterly budget forecasting for program. Identify tactics at risk and develop plans to mitigate risk of tactics identified. Maintain adherence to scope, budget, timelines, and risk mitigation plans. Responsible for vendor contracting for relevant tactics, management, and assess performance and adherence to SOPs.
Matrix Leadership
+ Works closely with MA Leadership Team members (MA-LT), Medical Affairs Committee (MA-C), Project Management Forum and other cross functional team members (including, Commercial, and external partners) to ensure full and timely implementation and execution of MA sponsored activities related to CMT, CMP, GPST and integrated plans.
Project Management Technical Expertise
+ Leads, develops, and executes strategies focused on Project Management, process improvements, system enhancements, industry benchmarking and organizational learning. Drives continuous improvement. Responsible for upgrading supporting infrastructure, resources, and tools to maximize process efficiencies. Leads Development and maintenance of excellence in strategic planning and project management oversight of all assigned MA activities, as well as project management methodologies, tools, and competencies.
+ Delegate for Head of Project Management for assigned initiatives and committees.
Medical Governance
+ Member and/ or Operations Leader of Project Management Offices and member of multiple task forces / committees to develop new processes and improve existing processes within the organization and governance model. Member / co-lead of PM Community, as relevant. Representation in PM Forum meetings or other global project management initiatives. Responsible to provide guidance and training on PM to Project Managers, and to other stakeholders as applicable.
Global / Regional (Geography) Additions
US
+ Lead, create, drive, and ensure effective project management to all aspects of the US Medical Brand Team (US MBT) functioning and collaborate with global PM members to ensure effective execution. Works in close collaboration with the US Med Brand Lead in the delivery of the CMP and all US MBT activities. Same responsibilities for the US Product Strategy Team working with the PST co-leads (Medical Affairs and Marketing Strategy) and chair. Monitors, tracks, and reports timelines, budgets, resources, and risks related to all US MBT and US PST activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Leads iGBP development.
+ Facilitates the logistics of US Medical Brand and US Product Strategy Teams.
+ Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.
Established Markets
+ Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.
+ Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks, and reports timelines, budgets, resources, and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Support Affiliates for CMP/CMT/Planning cycle related issues and provides input for reporting format and process. Pro-actively liaises with tactic owners. Close collaboration with product lead. Serves as a point of address for CMP/CMT/Planning cycle related issues. Provides input for reporting format and process. Pro-actively monitors issue management.
+ Facilitates the logistics of Regional Medical Team (RMT) meetings, CMP review meetings and processes.
+ Facilitation/Organization of RMT meeting, Updates/coordination to regional MALT meetings.
International Markets and GCN
+ Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.
+ Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks, and reports timelines, budgets, resources, and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Support Affiliates for CMP/CMT/Planning cycle related issues and provides input for reporting format and process. Pro-actively liaises with tactic owners. Close collaboration with product lead. Serves as a point of address for CMP/CMT/Planning cycle related issues. Provides input for reporting format and process. Pro-actively monitors issue management.
+ Facilitates the logistics of Regional Medical Team (RMT) meetings, CMP review meetings and processes.
+ Facilitation/Organization of RMT meeting, Updates/coordination to regional MALT meetings.
Japan
+ Accountable for project execution, tracking, team communication, and notification to Geography (region) MA-LT of milestones achievements, risks and issues related to tactics. Build and maintain collaborative relationships with internal and external stakeholders.
+ Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration with the Regional PMs in the delivery of the CMP and all CMT activities. Monitors, tracks, and reports timelines, budgets, resource and risks related to all CMT activities. Works proactively and in collaboration with all stakeholders to identify and manage constraints and risks, facilitating resolution. Support Affiliates for CMP/CMT/Planning cycle related issues and provides input for reporting format and process. Pro-actively liaises with tactic owners. Close collaboration with product lead. Serves as a point of address for CMP/CMT/Planning cycle related issues. Provides input for reporting format and process. Pro-actively monitors issue management.
+ Facilitates the logistics of Regional Medical Team (RMT) meetings, CMP review meetings and processes.
+ Facilitation/Organization of RMT meeting, Updates/coordination to regional MALT meetings.
Global
+ Accountable as the Data Governance Steward with focus on Core Medical Plan (CMP) tactics data quality and governance.
+ Develops new processes and improve existing processes within the organization and governance model.
+ Manages the logistics of the Benefit Risk Team (BRT) activities and MAPAC activities, essential document management, meeting logistics, and minutes.
+ Accountable for the data accuracy and quality of the CMP Tactic Submission Tool and CMP Progress Tracker as the Data Governance Steward. Includes the development of quality control steps / processes prior to go-live activities.
+ Responsible for the delivery of tactic analysis, pivot tables, presentation preparation, etc. in advance of key meetings for executive and senior leadership (MA-C, TA reviews, FY MA Annual Plan, Operational Excellence Leadership Forum).
+ Support the Director of Project Management with activities required for CMPs, departmental projects, and/or projects from the MA Head of Global Project Management.
**Quantitative Dimensions:**
+ Monitor, tracks, reports annual MA budget for assigned products, ensuring issues are reported efficiently with required level of detail. Member of cross-functional planning, budget and key Medical Affairs operational projects. Acts as department liaison to ensure transparency and implementation of organizational best practices and standards for Medical Affairs. Collaborates with other Medical Affairs members of region to ensure alignment within region or global, as relevant.
+ Core Medical Plan (Strategy and Operations) and GPST deliverables development and execution. US MA: US PST deliverables development and execution
+ Oversight and execution of assigned Medical Affairs product portfolio, including co-development partners, where relevant.
+ Proactively assesses constraints for their assigned programs and departmental projects to mitigate risks.
+ Contribute to divisional and corporate initiatives; influences the acceleration of all projects assigned to MA.
**Organizational Context** :
+ May report to Associate Director or Director or Head, Project Management, Medical Affairs in relevant structure e.g., global or region / affiliate.
+ Maintains strong working partnerships with Project Management peers and subject matter experts in Global/ Regions / Affiliates, Development, and Commercial. Maintains strong working partnerships with co-development partners.
+ Collaborates directly with TA Heads; MA-C member; CMT members; GPST members; regional PSTs; global, regional and affiliate MA; MAPAC; MA-C; E&C; Legal; PM Forum members; Budget & Control; Commercial; Development and key other stakeholders necessary to accomplish corporate and department goals. Collaborates with co-development partners and associated joint committees / joint teams.
+ Collaborates closely with external stakeholders: Key External Experts (KEEs) and vendors to lead and execute Advisory Engagements.
+ This role often works with a virtual team and may require infrequent travel.
**Qualifications**
**Required:**
+ Bachelor’s Degree and at least 7 years pharma industry (or related) experience, or Master’s degree and at least 5 years pharma industry (or related) experience.
+ At least 3 years project management, operations, or business analysis experience.
+ Strong written and oral communication, strong negotiation and influencing skills.
+ Significant knowledge of global drug development and product lifecycle management processes.
+ Significant knowledge of key interfacing organizations (finance, development, marketing).
+ Experience of leading and driving project management activities.
+ Ability to work in a matrix environment and function autonomously.
+ Demonstrated ability to manage multiple projects simultaneously.
+ Advanced use of word, PowerPoint, and spreadsheet software (PivotTables, etc.).
+ Good time management, planning and scheduling skills, strong attention to detail.
+ Team player, collaborative, relationship oriented, good decision and problem-solving ability.
+ Fluency in English, both written and verbal.
+ Strong ability to be proactive in identifying and managing project-related issues.
+ Strong ability to work effectively and collaboratively across a global organization, both cross-functionally and cross-culturally.
**Preferred:**
+ PMP certification
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
*LI-CH1
Category Medical Affairs - USA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-OH-Columbus) Clinical Sales Professional, Community Specialties - Columbus Northeast, OH2024-03-18T20:48:10-04:00https://astellascareers.jobs/0FAAC872429A43C8BF768B260C90180126**Clinical Sales Professional, Community Specialties – Columbus Northeast, OH**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Columbus Northeast, OH** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Sr. Vice President, Primary Focus Lead Immuno-Oncology (PFL-IO)2024-03-18T16:49:26-04:00https://astellascareers.jobs/F58AE512A89E415AB2A6369B2EC270B426Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois or Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
Sr. Vice President, Primary Focus Lead (SVP PFL) provides leadership and strategic direction for research, development, manufacturing, and commercialization of the Primary Focus pipeline globally. SVP PFL manages complex portfolio of including 20+ research and development stage projects and 4+ modality platforms. SVP PFL determines extension of PF, resource allocation and pipeline priorities, leads execution and accountable for related budget. SVP PFL chairs Primary Focus Immuno-Oncology Leadership Team (PFIO LT) and collaborates with the relevant Divisions to achieve Primary Focus goals.
**Essential Job Responsibilities:**
+ Create and revise PF Strategy to define the direction, capability and resource need of the diverse PF modalities and pipeline (EC)
+ Create the PF Roadmap to define execution plan and consolidated PF budget
+ Update strategy and roadmap driven by the rapidly changing scientific and competitive environment
+ Chairs PFIO LT, lead representatives of relevant functions to develop PF Strategy and implement the Roadmap, and guide Asset Teams and Research functions
+ Motivates and creates unique culture to drive high performance
+ Drives continuous investment into the PF, on order to evolve it and maximize its value
+ Monitors and reports progress of projects in each PF per Roadmap
+ Define the PF Business Development strategy to evolve Primary Focus. Collaborates with BD and CS to evaluate external assets and drives decision in Corporate Governance
+ Endorse project team’s proposal at KC
+ Creates PF budget and accountable for budget spending through Functional Units
+ Represents Astellas in committees and external scientific/ industry forums
**Quantitative Dimensions:**
+ Employee Headcount in matrix team: 150+ FTE in 5+ Divisions
+ Estimated Operating Budget: $250M R&D budget, PFL is accountable for planning and execution
+ Future revenue impact is significant
+ Global scope, impacts several divisions and /broad pipeline in multiple research and development stages
+ Other: strategy and milestone decisions impact overall value of Astellas pipeline and valuation
**Organizational Context:**
+ Leadership Roles: Core member of KC (portfolio governance). Chair of the PFIO LT. Chair of Joint Steering Committees of external research collaborations
+ Reports to Chief Strategy Officer (CSTO)
+ Executive Committee and other Governance Committee members
+ President of IO, Xyphos, UCELL, IRM, SVP of Development, Early Dev, Regulatory, BD, CS, Finance, Commercial, Market Access
+ CEO/CBO/CSO of partner biotech (Cytomx, Kalivir, Kelonia, etc.), other PFLs
+ Leaders of external companies related to BD and research activities
+ Key External Experts, Scientific Advisory Board Members
+ Represents Astellas IO in investor, business, scientific community
**Qualifications:**
**Required**
+ Master Degree. (MD, PhD, or PharmD preferred)
+ 15-20 years’ experience in cancer drug development in pharma industry
+ Capability to develop strategy and solutions for unprecedented, novel business areas
+ Capable of setting direction of complex matrix organization
+ Inspirational, collaborator both externally and internally
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution (RRSP in Canada)
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Primary Focus Lead, Immuno-Oncology
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-NJ-Toms River) Clinical Sales Professional, Community Specialties - Toms River, NJ2024-03-15T17:45:49-04:00https://astellascareers.jobs/B20864FFAFBC4E5080CD8C0A87DBACEE26**Clinical Sales Professional, Community Specialties – Toms River, NJ**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Toms River, NJ** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Director CCDS Labeling Strategy2024-03-14T16:49:26-04:00https://astellascareers.jobs/8802462D367F4C17862E66C3FD3CD7EC26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Director CCDS Labeling Strategy Lead will report to the Executive Director, CCDS and Labeling, and sit on the labeling leadership team. In collaboration with strategic regulatory, this position will be responsible for regulatory leadership and support (both technical and operational) in the area of CCDS (Company Core Data Sheets) and product labeling for key market products in all primary focus areas. This will include new products and life cycle management of existing portfolio. This position will function as a CCDS Labeling Lead for a key market product and will be responsible for all aspects of CCDS labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will have the responsibility of the CCDS Labeling Lead, providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLL) who are responsible for developing or managing CCDS and labeling content and ensuring consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.
**Essential Job Responsibilities:**
Key responsibilities include development of target product labels, CCDS and label development and supporting the development of key major markets Labeling across Astellas products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling documents.
This position will function as a CCDS Labeling Lead for products in all primary focus areas and will be responsible for all aspects of labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will also act as the Key Market Labeling Lead providing oversight to other Regulatory personnel including CCDS Labeling Leads (CLLs) who are responsible for developing or managing labeling content and ensure consistency across product labels. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will be responsible for leading the creation, implementation and maintenance of the CCDS applying scientific and clinical knowledge to the process. The position will understand and incorporate all key labeling guidance’s, FDA, Health Canada, Pharmaceutical and Medical Device Agency (PMDA), National Medical Products Administration (NMPA) and EU guidance’s into labeling strategies for those regions.
This position will be able to liaise with key regulators, FDA, Health Canada, PMDA, NMPA, and EMA for formal written and verbal negotiations. This position will participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. This position will assess impact of new labeling regulations and implement appropriate changes as well as lead development of company policy and position on draft regulations and guidance. This position will interact cross-functionally with members of RA, asset team, commercial, legal, safety, medical and others.
**Quantitative Dimensions:**
This position will have direct impact on the development and changes of CCDS and labeling, management/coordination of regional strategies of local labeling regarding implementation of CCDS updates, and labeling compliance for all Astellas marketed products in the key market regions. This position will have impact on the successful registration of new products, indications, and line extensions.
**Organizational Context:**
This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Medical Affairs, and affiliates members). The position reports to the Executive Director, CCDS and Labeling, Regulatory Affairs. The individual may have direct reports at the Associate Director and Manager levels.
**Qualifications:**
**Required**
+ Bachelor's degree (preferably in a life sciences field) with preference to higher degree.
+ Relevant experience in Regulatory Affairs in the area of labeling development and review for prescription pharmaceuticals or similarly regulated industry required (10 + year of relevant experience).
+ Excellent planning, organizational, analytical, problem-solving, and decision-making skills.
+ Ability to lead and motivate others.
+ Ability to drive projects to completion.
+ Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging.
+ Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.
+ Possesses excellent written and verbal communication skills.
+ Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.
+ Proficiency in a second language is a plus.
**Preferred**
+ Advanced degree (e.g., Masters, PhD, etc.,)
+ Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Biopharma RA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) Senior Medical Manager Oncology2024-03-14T09:45:27-04:00https://astellascareers.jobs/CC3C86FE98DA45699DAC7526539D1D2526**Astellas Canada – Senior Medical Manager, Oncology**
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
Astellas Pharma Canada (APCA) is currently searching for a Medical Manager, Oncology reporting to TA Lead.
**Description**
**** Responsible for the implementation of the medical strategy (Core Medical Plan) in the designated therapeutic area at the affiliate level by coordinating and executing medical / scientific activities to (i) understand the local external environment and data gaps; (ii) translate insights into strategies and activities and; (iii) ensure the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use of Astellas products. Specifically, this individual will:
+ Provide strategic medical and scientific expertise in support of all affiliate Medical Affairs deliverables and cross-functional activities
+ Demonstrate matrix leadership by developing and maintaining integrated partnerships with key internal and external stakeholders to ensure all MA affiliate activities address local needs and advance the medical/scientific understanding of Astellas products across their lifecycle
+ Responsible for understanding and engage external stakeholders to advance the understanding of and science behind compounds in development, the safe and effective use of Astellas products and disease states that they treat.
+ Responsible for engaging and working closely with key internal stakeholders, including the brand teams across the affiliate to achieve business objectives for the affiliate.
+ Ensures all affiliate MA activities deliver value and are based on scientific validity, clinical importance and on time & budget
** Essential Job Duties**
**Understand External Environment and Data Gaps**
**** Scientific Intelligence
+ **** Demonstrate thorough understanding of the therapeutic area, its current status, unmet needs and future developments
+ **** Engage external stakeholders (such as health care providers, payers and decision makers) and gather as well as share competitive scientific intelligence
+ **** Develop and maintain in depth scientific and medical expertise of assigned therapeutic area through self-study, company-provided training and scientific meeting attendance in order to enhance the contribution to the company
**** Advisory Boards
+ **** Conduct advisory boards as needed per the life cycle of the product to seek expert advice, opinions and feedback from advisors and other stakeholders on medical, humanistic, health economic or clinical topics related to marketed products or development-stage compounds to inform medical affairs and commercial strategies, plans
Medical Insights
+ Collaborates cross functionally with internal stakeholders to support communication of relevant scientific and medical insights to internal stakeholders
+ Oversee medical insights generation activities and ensure actionable insights are incorporated in strategic planning processes in collaboration with operational excellence and regional TA leads
**Translate Insights into Strategies and Activities**
Core Medical Plans (CMP)
+ Identify the unmet needs and develop suitable medical strategy to incorporate in the CMP as well ensure a compliant execution of all Affiliate Medical/Scientific activities (including vendor oversight) i.e., launch activities, educational programs, advisory / expert meetings, symposia in congresses
+ Ensure the affiliate CMP is aligned with Global CMP, Integrated global brand plan, as well as local brand strategies
+ Strategically leverage regional and/or global medical initiatives to meet local business needs, while maintaining an enterprise view
+ Implement the affiliate CMP tactics for the TA, on time and on budget as well as update CMP trackers on time
Collaboration Within M&D
+ Provide reactive support to development team to identify potential study investigators / sites and assist with feasibility study execution for registration studies.
+ Provide scientific/medical support to regulatory affairs on submission of dossiers and presentations upon request
+ Provide scientific/medical support to regional clinical operations and/or pharmacovigilance teams in execution of mandatory post-approval studies as needed.
+ Partner with Regional Operational Excellence team to provide regular input to monthly reports for the General Manager/Regional President/Chief Medical Officer
Collaboration with Commercial
+ Provide strategic scientific/medical expertise in support of all cross-functional activities (Marketing, Market Access, Business Intelligence, Sales)
+ Champion a collaborative mindset to ensure full alignment with key stakeholders cross-functionally
+ Review and approve promotional materials complying with local and applicable internal/external regulations and/or policies.
+ Provide scientific /medical support to Marketing, Market Access, Business Intelligence (advice, reports, recommendations, etc.).
+ Coordinate in executing medical-scientific activities in product launches: disease area presentations, expert meetings.
+ Participating as a therapeutic area/product expert in internal meetings of the company and provide medical-scientific support for external meetings in a fair and balanced manner (post-approval symposia)
+ Provide consistent training on therapeutic area and products to the colleagues (including commercial) in the affiliate
**Fulfill Information Needs of External Stakeholders**
**** Data Generation for HCPs and Payers
+ **** Partner closely with the Health Economics and Outcomes Research (HEOR) and Market Access to provide insight on local access strategies and challenges and close data gaps
+ **** Plan and develop HEOR data generation projects, not limited to Budget Impact Model/ Cost-effectiveness analysis
+ Partner with market access in reimbursement or listing discussions with payers/hospitals as needed
Data Communication and Medical Education
+ Provide medical / scientific education and training to internal stakeholders on marketed products and compounds in development
+ Acts as local scientific/medical expert to regional Medical Information group (i.e., escalated inquiries), ensuring all local regulatory requirements are met and in compliance with Astellas procedures and ethical standards.
+ Strategically manage the development of local Non-Promotional Medical Materials in alignment with TA/ affiliate objectives, including, but not limited to slide presentations and posters / manuscripts
+ Identify and engage key external customers (KEEs) in in-depth medical and scientific product or disease area discussions / scientific exchange, and presentations to communicate the value of Astellas products in a fair and balanced way in accordance with Astellas values/code of conduct as well as applicable local regulations
+ Develop, maintain, engage with key external experts (KEEs), healthcare professionals, healthcare organizations funding bodies and other entities to engage and communicate the value of Astellas products in a fair and balanced way accordance with Astellas values/code of conduct as well as applicable local regulations
External Program Funding for Research and Education
+ Support the affiliate head and regional reviewers in reviewing as well as appropriate documentation of Investigator Sponsored Research/ Grants for general research/ Grants for Medical Education/ Sponsorship for Research & Education
+ Obtain post-activity evidence, including financial reconciliation documents to confirm that the provided grant support was utilized according to the executed legal agreement and this is documented in the applicable system
**Required Qualifications**
+ Doctoral degree (MD, PhD in health-related science or PharmD)
+ 5-7 years’ experience in Pharma.
+ 3-5 years in Medical Affairs
+ Suitable candidates from academia with Strong expertise in the therapeutic area including clinical/ hospital practice, clinical development, experience in designing, executing and reporting of clinical trials can be considered.
+ Strong understanding and knowledge of industry laws and regulations.
+ Experienced in managing complex projects and effectively act independently g., Ad Boards, Publications, Preceptorship).
+ Demonstration of ability to effectively interact in a matrix organization with matrix reporting lines.
+ Proactive strategic partnering with different internal functions g., Commercial, Market Access, HEOR.
+ Excellent presentation skills and advanced written and verbal business English.
+ Foundational understanding of the drug development process as well as commercialization.
+ Ability to travel 20-30% of the time including overnight travel
**Preferred Qualifications**
+ **** Contributing to / supporting onboarding and development activities for colleagues e.g., acting as a buddy, mentor or coach
+ Demonstration of delegated responsibilities successfully completed e.g., acting as a backup for a Therapy Area Lead at key internal or external meetings.
****
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
*LI-CH1
Category Medical Affairs - Established Markets
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) GMP Technical Biopharma Trainer2024-03-13T09:45:28-04:00https://astellascareers.jobs/EC84E41D652D40BEB74BD353F494E19B26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute of Regenerative Medicine (AIRM** ) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **GMP Technical Biopharma Trainer** opportunity at our **Astellas Institute of Regenerative Medicine (AIRM)** site in **Westborough, MA** . This is an **onsite position** .
**Purpose and Scope:**
The GMP Technical Trainer role typically reports to the Director or Sr. Director, Manufacturing Science and Technology and is responsible for developing and executing training curricula for GxP personnel, coordinating cross-functional training, maintaining oversight and execution of GMP training to maintain operator proficiency and compliance. The GMP Technical Trainer role develops training strategies that identify curriculum, training format, and evaluate training effectiveness. Monitors KPI’s relating to training effectiveness. The GMP Technical Trainer incumbent will act as the SME for audits and inspection readiness preparedness activities. This position supports the ongoing manufacture of preclinical and clinical trial materials by providing timely and compliant training program administration and classroom training.
**Skills:** cGMP, aseptic techniques, cell culture basics, cleanroom behavior, cell therapy, Biopharmaceuticals, training curricula design, hands-on training
**Essential Job Responsibilities:**
+ Develops individualized and group training programs that address specific business needs.
+ Work closely with drug product development and peers within Manufacturing Science and Technology to ensure that any new tools or methods are adequately supported by appropriate training materials.
+ Establishes and/or revises technical educational training materials including but not limited to videos, guides, SOPs, and Work Instructions. Trainings are not limited to aseptic processing and qualification, cell culture technique, regulatory requirements such as GMP Documentation, cleanroom behavior, cGMP/ISO, and laboratory safety.
+ Develops a training schedule, coordinate staffing and scheduling of all training activities.
+ Delivers training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
+ Creates processes that enable timely and actionable performance feedback of trainees.
+ Fosters a culture of continuous improvement and operational excellence. Provide guidance/support to help trainees feel motivated and supported.
+ Act as Training SME for audits and inspection readiness activity.
+ Establishes key performance indicators (KPI) to measure training effectiveness. Evaluate organizational performance to ensure that training is meeting business needs and improving performance.
+ Conducts post-training evaluation of technique and application after a designated period.
+ Facilitates timely resolution and closeout of CAPAs specific to Training issues.
+ Partners with GMP Manufacturing, QA and Manufacturing Technical support to identify technical training needs and design, implement and deploy an effective and comprehensive training program while identifying improvements to the existing training curriculum.
+ Coordinates training related to business needs, organizational goals, and operational excellence/improvement initiatives.
+ Under direction of the department head, Manages resources applicable to execution of training program and laboratory maintenance.
+ Support Tech Transfer initiatives.
+ Other duties as assigned.
**Quantitative Dimensions:**
This role will ensure the delivery of GLP and GMP material by ensuring manufacturing systems and practices are consistent, follow AGT/MA-TC policies and procedures, regulatory requirements, guidelines, and recommendations. They will seek out, initiate, and lead process improvements, and under direction of management, will provide all training and resources to the Manufacturing staff. This role serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations.
**Organizational Context:**
The role, will typically report a Manager, Sr Manager, Associate Director OR Director of Manufacturing OR MS&T. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies/MA-TC and the Astellas organization.
**Qualifications:**
**Required**
+ BS / BA in Chemical/Biological Engineering or Life Sciences plus 5+ years of experience in life sciences in manufacturing operations roles or Associates Degree in Science or related field with 7+ or H.S. diploma with 10+ direct related industry experience.
+ Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug Product operations and demonstrated experience and ability to comprehend technical information as it pertains to equipment and processes.
+ Prior work history requiring working independently, with minimal supervision. Demonstration of leadership, working with and/or leading cross functional projects/project management; along with proven ability to proactively adjust work to meet changing business needs.
+ Demonstrated success and desire to work with/ in a fast-paced environment and influential skills with coworkers and cross-functional key stakeholders.
+ Strong attention to detail supported by excellent time management and organizational skills. proficiency with MS Office (Excel, PowerPoint, Word, MS Project, and MS Visio), and proven ability to work in faced paced changing environment.
+ Experience in leading classroom and OJT trainings of GMP personnel and direct hands-on experience with GMP Cell Therapy operations.
+ Good written and verbal communication skills and experience communicating with all organizational levels.
+ Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
**Preferred**
+ Industry experience in Drug Substance and Drug Product and knowledge or proficiency with single use equipment and systems and cGMP and good documentation practice (GDP).
+ Experience with Quality Systems, RCAs, and investigational ownership.
**Working Conditions**
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25 lbs.
+ This is an on-site role working in a cGMP regulated manufacturing facility.
+ On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS1
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) 2nd Shift, Manufacturing Associate I2024-03-12T20:48:11-04:00https://astellascareers.jobs/239A5BBE970D481C9AAA3D3B181AE28F26**2** **nd** **Shift Manufacturing Associate I**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **2** **nd** **Shift** **Manufacturing Associate I** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**
**Purpose:**
The Manufacturing Associate I role will be a contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and is an entry level role in an operations environment. This includes equipment testing, SOP/batch record collaboration, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
**Essential Job Responsibilities:**
+ Perform all manufacturing operations under cGMP/ISO requirements
+ Assist with the installation, commissioning, and validation of equipment within single use facility
+ Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
+ Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process; may support additional operational projects as assigned
+ Maintain a high level of quality and compliance with regards to all aspects of manufacturing
+ Maintain 100% on-time training completion in learning management systems, completing downstream on the job training curricula as required
+ Display ability to identify and escalate potential GMP issues, as required
+ Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
**Quantitative Dimensions:**
The Manufacturing Associate I will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.
**Organizational Context:**
The Manufacturing Associate I will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene and Cell Therapies and the Astellas organization.
**Qualifications:**
**Required:**
+ 0-2 years of experience working in a GMP manufacturing environment – applicable certifications are encouraged with no industry experience
+ Strong skill on biological laboratory math
+ Knowledge of aseptic technique
+ Strong communicator with ability to work effectively both independently and as part of a team along with capacity to maintain detailed records and ability to assist in document revisions
+ Proven ability to establish and maintain effective working relationships with team members and managers.
+ Will support and demonstrate quality standards to ensure data of highest quality
+ Strong communicator with ability to work effectively both independently and as part of a team
+ Models our Core Values: Be Bold, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Will be expected to perform other duties and/or special projects, as assigned
**Preferred:**
+ BioWork Certification or related certifications along with technical understanding of a biotech manufacturing facility are a plus
+ Understanding of cGMPS as related to commercial and clinical operations
+ Capacity to learn an ability to develop technical proficiency towards the use of general MFG equipment
+ Experience with single-use technologies and understanding of FDA regulations
+ Strong computer skills including MS Office (Word, Excel)
+ Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
+ Ability to support general investigations and CAPA execution
+ Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-TD**
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-NY-Bronx) Clinical Sales Professional, Community Specialties - Bronx, NY2024-03-12T16:53:41-04:00https://astellascareers.jobs/9DE1EA3A509B4ABE9FC480728709A90326**Clinical Sales Professional, Community Specialties – Bronx, NY**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Bronx, NY** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Salary Range:**
+ $78,800-$105,000 (NOTE: Final salary could be more or less, commensurate with experience)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) Clinical Development Scientist, Oncology2024-03-07T21:48:15-05:00https://astellascareers.jobs/8E0B6C2B5BF44F71A18A739A6E924E1226At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope:**
The primary purpose of the Development Scientist will participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, and Asset Lead, and Medical Monitor, and is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.
**Essential Job Duties:**
+ Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
+ Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
+ Serves on the clinical sub-team with GML, Operations Lead, and Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings.
+ Under the guidance of study physician/med lead, perform medical monitoring activities (Review, analyze and triage patient data, generating reports
+ Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
+ Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries.
+ Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions.
+ Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
+ Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
+ Early and/or late phase studies
+ Exhibits expertise related to Study Data Review and Analysis:
+ Provides clinical input into statistical planning, data analysis and interpretation
+ Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
+ Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
+ May lead the execution of contracts, particularly for investigator meetings and advisories.
+ Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
+ Serve as key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape and clinical characteristics.
+ May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
+ Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
+ Performs other duties as assigned or special projects as needed.
+ This position reports to the Primary Focus Medical Head (or other Leads depending on grade) for designated program.
+ This position is typically an individual contributor role, but may have direct reports based on scope, accountabilities and complexity of assigned development programs. If position has direct reports, will align with Astellas guidelines for span of control and organizational levels.
**Required Qualifications:**
+ Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-8 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry.
+ Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
+ Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
+ Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
+ Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
+ Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
+ Knowledge of global pharmacovigilance standards and guidance documents.
+ Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
+ Excellent strategic planning, organizational and verbal and written communication skills.
+ Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions. Highest level of scientific integrity.
+ Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
+ Able to travel ~25%, with international travel at times
**Preferred Qualifications:**
+ PhD. or PharmD degree, or other relevant Master’s degree.
+ Knowledge and proficiency related to Medical Affairs activities including registries.
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
Category Oncology Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Animal Care Technician2024-03-07T17:49:37-05:00https://astellascareers.jobs/D21585E7F1594772BC05AF1626FB3D9126**Animal Care Technician**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Animal Care Technician** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**
**Purpose:**
The Animal Care Technician will be responsible for performing operational, administrative, and technical tasks to provide comprehensive care of Rodent species, including daily health observations, cage change, animal health care, study support, breeding colony support, cage wash, supplies procurement and receipt, and vivarium sanitization as well. Must be able to lift 50 lbs. and move heavy objects and be able to work from a standing position for prolonged time periods and perform repetitive motion tasks. This role is scheduled for Monday - Friday (days), but must be available to support weekend, work or a split shift (Tuesday- Saturday or Sunday- Thursday), holiday, emergency, and after-hour operational responsibilities as needed. Other duties as assigned and required.
**Essential Job Responsibilities:**
+ Perform Rodent husbandry duties such as daily animal health check, cage change, room parameters (temperature, humidity, etc.) check and waste disposal.
+ Apply basic veterinary care and treatment of rodents as needed and per the instructions of the attending veterinarian and/or the vivarium manager
+ Perform routine maintenance and sanitization of rooms and associated equipment within the vivarium.
+ Keep work areas stocked with supplies as needed for operation and study work.
+ Maintain housing, procedure and washroom records: e.g., room logs, sanitization records, census and inventory records, etc.
+ Receive and house rodent orders.
+ Conduct weekly census of cages and supplies inventory
+ Conduct washroom tasks e.g. washing and sanitization of cages, enrichment, storage containers.
+ Assist with administrative tasks e.g. printing out cage cards, logs, census sheet, signs, forms, etc.
+ Assist with animal and supplies procurement.
+ Provide support to rodent breeding colonies e.g. breeding cages setup, litters weaning, animal Identification and sample collection for genotyping.
+ Perform injections (IP/PO/SC/IM/IV) and sample collections (blood, tissue collection and necropsy) for both mice and rats as needed.
+ Perform imaging procedures (IVIS/OCT) as needed.
+ Assist with training of the research staff on basic animal handling procedures, Microisolator procedures, rodent injections (IV/IP/SC, etc.) and sample collections (blood samples and tissue collection) as well.
+ Participate in the draft and review of operational SOPs.
+ Perform other duties as may be required.
**Quantitative Dimensions:**
+ Direct impact to Facilities, Research, and Technical Operations operating budgets
+ Direct impact to costs of contracts through strategic negotiations
+ Direct impact to Facilities, Research and Technical Operations objectives
**Organizational Context:**
+ Reports to the Vivarium Sr. Manager at AIRM
+ Partners with research groups to provide an optimum care of the research animals and quality support of the in-vivo research projects
**Qualifications:**
**Required:**
+ Associate degree or equivalent
+ 2-3 years of hands-on experience in research, rodent husbandry, breeding and technical support
+ Strong Microsoft office skills (Word, Excel, Powerpoint)
+ strong interpersonal and communication skills (written, verbal)
+ strong commitment to providing quality work, and dedicated to high standards of animal care and welfare, in accordance with all guidelines and regulations pertaining to Laboratory Animal Care
+ Reliable, able to work equally well, whether independently or as part of a team.
+ Demonstrate a high level of attention to detail in delivering quality and consistent results in the conduct of all daily operational and technical duties.
**Preferred:**
+ BS degree is highly preferred
+ AALAS-ALAT certification is highly desirable
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-TD**
Category IRM-Operations & Transformation
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MO-Kansas City) Healthcare Systems Specialist - Kansas City, MO2024-03-07T10:47:21-05:00https://astellascareers.jobs/19FB75E61D1542D5BA2592EE54272CA726**Healthcare System Specialist – Kansas City, MO**
The Healthcare Systems Specialist has multiple responsibilities around the promotion of Astellas products and resources to a variety of stakeholders within Healthcare Systems, such as Doctors, Nurses, Pharmacists, Hospital Administrators, Discharge Planners, and Buyers. Educating customers on characteristics, indicated treatments related to assigned promoted products and. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction.
The Healthcare Systems Specialist plays an important role in establishing effective communications and relationships with key external and internal customers within Healthcare Systems.
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
**Primary Responsibilities**
+ The primary responsibility of the Healthcare Systems Specialist is strategic account selling and engaging key stakeholders within complex healthcare systems, such as the Healthcare Providers and support staff, Service Line Managers, Specialty Pharmacists, Fellows, Hospitalists, Transition of Care Coordinators, and Supply Chain Managers, to achieve sales objectives across the Astellas portfolio of products.
+ The primary responsibility of the Healthcare Systems Specialist is strategic account selling and engaging key stakeholders within complex healthcare systems to achieve sales objectives across the Astellas portfolio of products.
+ Develop expertise and understanding of Healthcare Systems, market dynamics, stakeholder mapping, inpatient/outpatient network navigation. This includes developing and executing Strategic Key Account Plans, providing account strategies.
+ Demonstrate ability to quickly learn and embrace new ways of working in a rapidly changing environment.
+ Proactively identify business opportunities to drive and develop business.
+ Overcome obstacles to access difficult to see healthcare providers and customers.
+ Accountable for establishing working relationships with a broad base of stakeholders to promote and educate on the use of Astellas products through one-on-one meetings, presentations, speaker programs and other appropriate means.
+ Collaborate and align efforts with internal Astellas stakeholders to engage with key healthcare systems including compliant partnership with other sales teams, medical, and market access teams.
+ Responsible for ensuring high levels of call and field productivity, expected to meet call plan expectations, with 5 days in the field each week, supported by office time needed for call planning and follow-up, preparing presentations, making appointments, etc.
+ Responsible for accurately reporting sales activities, testing, territory expenses and submitting written reports as necessary by the deadline set forth as defined by company expectations.
+ Appropriately manage and maintain all company equipment and promotional materials (company literature, materials, etc.) according to necessary company guidelines
+ Attend all company-sponsored sales and medical meetings as directed by company management (POA's, National Sales Meetings, Regional and Local Conventions, etc.)
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individual’s in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge
This position:
+ is a first-line customer facing sales position
+ Reports to Regional Manager Healthcare Systems
+ Maintains territory responsible for managing Astellas' products within Healthcare Systems
+ Balances territory and regional work and projects, while maintaining strong level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence beyond territory and at times within region
**Qualifications**
**Required**
+ BA/BS degree
+ At least 4 years overall pharmaceutical or healthcare selling experience with promoting primary care or specialty sales
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Proven track record of successful sales results and ability to meet or exceed objectives
+ Proven capability in managing accounts with solid selling competencies
+ Strong communication, facilitation and presentation skills
+ Continuous learning and a growth mindset
+ Proactive; can do approach; takes ownership of situations
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation
+ Proficient in MS Office Suite
+ Ability to travel as required
+ Valid driver’s license in good standing
+ No criminal convictions resulting in suspension/revocation of driving privileges within the last 3 years
**Preferred**
+ At least 2 years successfully promoting products and services with multidisciplinary customers, pulling through formulary placement, throughout healthcare systems
+ Previous successful product launch experience within individual accounts and healthcare systems
+ Experience in infectious disease, rare disease, oncology, and women’s health
+ Advanced degree
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Flexible pay grade level, based on candidate background and skillset
**\#LI-DM**
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Commercial Excellence Partner2024-03-07T10:47:20-05:00https://astellascareers.jobs/B627E3A046E741B59EBDFB1407F5BDE226Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Commercial Excellence Partner will support the Director, Commercial Excellence and Operational Excellence in developing and implementing Astellas capabilities, processes, and governance to optimize product launch, life cycle management and ongoing commercialization capabilities and operational excellence support across the organization until the end of the product’s lifecycle. The Senior Manager is a key member of US Commercial Excellence (Com Ex), part of US Strategy & Planning (USSP)), for Astellas US Commercial (US-C). This individual will be an active partner in engaging with multiple stakeholders across multiple functions to establish and embed robust, agile, and consistent practices to US-C strategic initiatives in a matrixed organization. Key business partners include product general management and product teams, among others.
**Essential Job Responsibilities:**
+ Provide leadership and subject matter expertise in the areas launch excellence, loss of exclusivity planning, and life cycle management, as well as other commercial and operational excellence strategic initiatives within US-C.
**Launch Excellence / Loss of Exclusivity / Life Cycle Management:**
+ Lead a consistent and robust lifecycle management discipline, with supporting processes and governance structure, in close collaboration with the US product organization and US functions.
+ Work with internal launch collaborators to ensure successful and timely launch process management and completion of launch readiness tasks (standardized approach across brands)
+ Lead Astellas US planning for Launch Readiness Reviews (LRR) and meetings for launch products and ensure alignment of LRR calendars with other key processes.
+ Capture launch lessons and best practices in collaboration with launch teams; build up and curate central repository of institutional knowledge around US Launch Excellence
+ Provide daily operational, business planning and strategic communications support to the Director, Commercial and Operational Excellence and ad-hoc operational, business planning and critical communications support to the Executive Director of US Commercial Strategy and Planning
+ Develop launch plans, manage timelines, and monitor key performance indicators to measure launch effectiveness.
**Commercial and Operational Strategic Initiatives for US-C:**
+ Lead project execution of US corporate strategic initiatives or select non-enterprise initiatives that drive growth for US-C. Project execution includes but is not limited to developing business cases, project charters and governance, providing updates to senior leadership, developing, and reporting milestone updates of project implementation and monitoring to ensure successful outcomes, facilitating and leading effective project meetings, managing change and conflict, developing resource planning estimates, and managing timelines and budgets.
**Quantitative Dimensions:**
+ This position drives the successful execution of US strategic initiatives as outlined in this job description in support of the commercial function to ensure outcomes aligned to business goals impacting the performance of Astellas US-C are achieved. It also is responsible for collaborating with other related functions (e.g. Ethics & Compliance, Medical Affairs, Commercial Strategy & Capabilities) on projects/initiatives as needed.
+ Budget management and tracking for the respective strategic initiative/s managed by this position directly are also key areas of impact for the position.
**Organizational Context:**
+ Commercial Excellence is a highly collaborative function integrating business strategy into, and ensuring, implementation is well orchestrated within a defined governance framework. This position will require a high degree of communication with self-leadership, as well as collaboration with internal colleagues across multiple functions.
+ This position will report to the Director, Commercial and Operational Excellence. This position may have external resources reporting indirectly depending upon needs of initiatives being executed.
**Qualifications**
**Required:**
+ Bachelor’s Degree with a minimum of 7+ years’ experience (or advanced degree in related field with a minimum of 5+ years) in executing large, cross functional or global initiatives using a project management framework within business operations.
+ Experience within Healthcare and/or pharmaceutical industry
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage multiple cross-functional projects simultaneously.
+ Demonstrated leadership in a matrix organization, able to motivate and inspire team members to high performance levels.
+ Proven decision-making skills leading to successful outcomes.
+ Demonstrated ability to present complex issues to higher level management and contribute to high level presentations and discussions.
+ Demonstrated ability to develop and maintain effective collaborative relationships with team members, management and internal/external partners.
+ Demonstrated ability to be a consistent high-level contributor or leader of multiple projects, processes, or functions.
+ Ability to lead and support cross-functional teams to deliver against common goals.
+ Strong communication, conflict resolution, and leadership skills
+ Demonstrated experience influencing without authority.
+ Proven track record of success being a high-level independent and team contributor to lead multiple projects and processes
+ Experience working with teams / individuals with varied cultural backgrounds & learning styles
+ Intermediate to advanced competency and experience with a variety of computer applications, including Microsoft Suite, MS Project, SharePoint and/or other related project management tools
+ Willingness to travel (approximately 10-20%)
**Preferred:**
+ Advanced degree, with experience in healthcare and/or pharmaceutical industry and management consulting
+ Demonstrated understanding or experience in commercial strategic and/or business planning and governance
+ Experience managing both internal and external resources (including remotely)
+ PMP, Six Sigma or other equivalent project management and/or process improvement advanced certification(s)
+ Specialized training or equivalent experience in product launches or product commercialization
+ Experience with using Clarizen or other such project management software
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category US Strategy & Planning
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) People Partner2024-03-05T21:53:09-05:00https://astellascareers.jobs/E64CABEDCC174D56B902CAEDD2295AD726**Astellas Canada – People Partner**
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
Astellas Pharma Canada (APCA) is currently searching for a People Partner reporting to People Partner Cluster Lead.
**Description**
The People Partner:
+ Is responsible for providing multi country case management support to employees and managers which have been escalated by the HR Service Delivery Team.
+ Will provide multi-country policy expertise and HR generalist knowledge to support and educate leaders, managers, and associates on all People topics. People Partners support all customer groups and enable the delivery of all life cycle events.
+ Is responsible for resolving employee relations issues, support and advise leaders on HR-related matters & policies.
+ Is responsible for the delivery of Case Management (i.e., underperformance, disciplinary, grievance and sickness absence), business changes, in-country projects, and cyclical HR processes on behalf of Global HR Business Partners and Centres of Excellence in addition to providing support for employee relations queries.
+ Is responsible for delivering a legally compliant HR service in line with identified needs.
+ Is responsible for providing data and insights on the volume of activity, trends, issues, concerns, and success stories.
+ Will report to the People Partner or People Partner Cluster Lead and will work closely with other HR teams, across the broader HR function and directly with the business
**Essential Job Duties**
**Key Accountabilities:**
+ Responsible for the provision of legally compliant and sound advice and guidance provided to managers and employees on a variety of case management issues
+ Responsible for all employee relations Case Management (i.e., underperformance, disciplinary, cross border, grievance and sickness absence)
+ Responsible for executing a portfolio of business change projects and in-country projects in collaboration with HRBPs
+ Responsible for providing support to HR Business Partners and Centres of Excellence to execute the delivery of cyclical HR processes (i.e., Talent, Rewards)
**Key Deliverables:**
**Case Management:**
+ Provide solutions to resolve case management queries escalated from the Service Delivery Team
+ Provide advice, guidance and support to managers and employees on case management issues (i.e., underperformance, disciplinary, cross border, grievance and sickness absence) and policy interpretation
+ Identify and analyse legal and compliance risks in employment situations and partner with the HR Business Partner & Employee Relations team to mitigate accordingly
+ Keep up to date with employment law and employment law trends
+ Monitor and track trends in case management queries to proactively identify issues and identify opportunities to overcome these trends
+ Escalate complex case management queries to HR Business Partners & Employee Relations as appropriate
**Execution of Business Change Projects:**
+ Collaborate with Subject Matter Experts and HR Business Partners to deliver end-to-end business change projects (for example- business restructure)
+ Work closely with broader HR Project teams to deliver in-country project work
+ Manage multiple projects; identifying risks, dependencies, overlaps and conflicts (both within and outside of HR) and ensuring deadlines and deliverables are met
+ Maintain a mind-set of continuous improvement to identify opportunities to improve the services provided by HR
**Delivery of Cyclical HR Processes:**
+ Collaborate with HR Business Partners and Centres of Excellence to execute and deliver cyclical HR processes (e.g., talent, performance and reward cycles)
+ Act as a thought partner to HR Business Partners and Centres of Excellence to ensure that global solutions work locally and that local HR requirements are met
+ Execute activity on behalf of Centres of Excellence teams for processes that are outside of the scope of services provided by the Shared Service Centre
**Ways of Working:**
+ Collaborate with Legal, Ethics & Compliance, HR Business Partners and Centres of Excellence to provide the appropriate level of support required
+ Work supportively and collaboratively with other teams across HR
+ Maintain a proactive approach, taking the initiative and managing self effectively
+ Build relationships and trust with key stakeholders
+ Seek opportunities to continually improve the services provided by HR
**Required Qualifications**
+ Education – bachelor’s degree
+ Years of working experience: 5+ years
+ Experience in managing high risk employment-related cases from intake to investigation to resolution
+ Proven experience function as a natural collaborator who is authentic, transparent and aligns with the Astellas values and code of conduct
+ Proven success partnering and collaborating with stakeholders’ cross-functionally and at all levels
+ Strong analytical skills and ability to exercise sound judgement based on policies, procedures, practices, and risk factors
+ Excellent interpersonal skills with an ability to inspire trust and confidence and effectively influence the decision-making process
+ Self-starter and ability to manage a workload of varying complexity to a high standard
+ Experience across core HR functions (e.g., Compensation, Benefits, Performance Management, etc.) with specific experience in HR process design, transaction support and employee administration
+ Fluent in English and at least one other European language
+ Continuous Improvement knowledge
+ Personal computer skills, including MS Office and Outlook
+ A broad understanding of the HR employee lifecycle
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
***LI-CH1**
Category HR Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-CA-South San Francisco) Senior Engineer, Lab Systems and Applications2024-03-05T10:45:29-05:00https://astellascareers.jobs/7756949FEE2D4C3E9556C1BF0B00A17F26**Senior Engineer, Lab Systems and Applications**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **www.astellas.com** .
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
**The Role**
As part of the Data Systems & Controls team, the Senior Engineer, Lab Systems and Applications will deliver IT support for our pilot plant and research laboratory systems, working onsite at our South San Francisco, CA location. This role requires advanced technical skills and a strong focus on customer service and systems ownership. The Principal IT Systems Engineer must be a team player that understands the importance of collaboration and can drive projects and the resolution of issues to completion with minimal supervision and effective utilization of vendor and contract resources. Some travel may be required.
**Primary Responsibilities**
+ Leads projects to deliver or enhance systems and applications through researching technologies, developing solutions or roadmaps, and drafting design and configurations to meet the needs of stakeholder group requirements
+ Leads computer system validation and is responsible for qualification protocols, summary reports, exception resolutions, data collection and analysis, and UAT planning and coordination
+ Responsible for systems ownership, administration, and deployment including routine preventative maintenance, change control, procedure development, and technical assistance to operations
+ Investigates and troubleshoots technical problems of increasing complexity, utilizing system documentation, and addresses system outages/issues impacting operations by identifying, prioritizing, and resolving issues
+ Monitors and verifies acceptable performance and accessibility of newly deployed IT solutions and performs investigations and deliver corrective actions, as required
+ Supports the Digital Analytical Technologies team in the implementation of network and infrastructure changes impacting the lab and production systems and applications
+ Monitors and troubleshoots daily system backups and develops, tests, and maintains disaster recovery procedures
+ Work schedule includes ‘out of normal’ work hours for IT support, maintenance, or other activities as required
**Organizational Context:**
This position is a technical and team leadership position reporting to the Associate Director, Data Systems & Controls within the Astellas Gene Therapies Research & Technical Operations Division.
**Required Qualifications**
+ BS/BA degree in engineering, information systems or equivalent with a combination of education/work experience
+ 8+ years of relevant IT or IS environments and solutions, in an administrator or technical expert role
+ 6+ years of supporting IT or IS in a biotechnology or pharmaceutical lab or manufacturing environment
+ Experience provisioning new IT solutions in support of business processes
+ Experience with computer system validation
+ Experience using multiple tools to collaborate remotely with staff and contractors
+ Demonstrated understanding of IT Support as part of a business function (SLA’s, ITIL practices, etc.)
+ Strong technical writing and oral communication skills
+ Models our Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
**Preferred Qualifications**
+ Experience with validated environments, change management, and regulations
+ Experience with systems including MFCS/win, UNICORN, OSI PI, Schneider BMS, Vaisala EMS, Benchling, and Signals
+ Experience with designing information interfaces, data conversions, and network and infrastructure fundamentals
+ Experience designing and configuring applications that integrate Information Technology networks with Operation Technology equipment
+ Experience supporting users, applications, lab equipment, and instruments in lab and pilot plant environments
Working Conditions
+ This position will be hybrid, with onsite work required at least 3 days per week and will require less than 10% travel.
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
**Salary Range** **:** $112,500-$150,000 (NOTE: Final salary could be more or less, based on experience)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-TR1
Category Gene Therapy Research & Technical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-TX-Dallas) Regional Sales Manager Community Specialties - Dallas, TX2024-03-04T18:45:53-05:00https://astellascareers.jobs/321FC5F8F87E438B8A77B7E11F5F97BA26**Regional Sales Manager, Community Specialties –** **Dallas, TX**
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Regional Sales Manager – Community Specialty opportunity in the **Dallas, TX** area.
**The Role**
The Regional Sales Manager primary purpose is coaching, leading, motivating, developing and hiring sales professionals. Provide the leadership necessary to achieve sales goals for Astellas’ products and services within a region. Maximize business growth through close collaboration with Area Director, Marketing, Managed Markets Manager, and Training and Development. Manage Sales Professionals and provide consistent and uniform direction to team regarding execution of sales and marketing strategies and tactics. Develop the field team within the region, focusing on managing performance and career progression. Ensure the optimal allocation of resources across the region and maintain effective communication and relationships with key external and internal customers.
**Primary Responsibilities**
+ Identify and maximize talents on the team. Provide growth opportunities, development and appropriately distribute rewards/recognition and development where appropriate based on the sales professionals achievements and performance.
+ Coach and counsel sales professionals on improving selling skills, product knowledge, and capabilities needed for successful development. Regularly participate in field visits with sales professionals to assess their growth and development in territory management, sales strategy and approach.
+ Foster proactive and open communication within team and set expectations and high standards of performance for each team member. Establish and maintain an effective communication system among regional sales professionals and across regional boundaries.
+ Demonstrate strong and clear leadership through consistent communication and direction, and assume direct responsibility for achieving sales goals within region. Maximize productivity and sales effectiveness within region by executing sales and marketing plans and promotional activities.
+ Analyze selling opportunities to identify top priorities and drive market share through project implementation. Direct and align efforts related to business strategic plan; ensure that Astellas’ long-term goals are achieved in region; effectively allocate resources and manage region budget; and monitor and understand sales trends and competitor activities.
+ Manage and understand trends and human resource needs related to recruitment, performance management, selection and development.
+ Lead region recruitment and development programs, suggesting improvements based on experience to achieve diversity of talent.
+ Provide ethical leadership and demonstrate Astellas’ values by adhering to corporate policies and required sales practice regulations. Ensure each Sales Professional within region understands, accepts and adheres to the policies and procedures.
+ Awareness and understanding of the Corporate Strategic Plan and Organization Health Goals
+ Additional duties as needed.
**Quantitative Dimensions**
+ Responsible for achieving 100% goal attainment for multiple products within a sales region that on average contains nine (9) territories.
+ Interacts with internal Astellas departments and external customers, such as Key Opinion Leaders.
+ This position is responsible for achieving regional product sales and activity goals and managing team travel budgets, exhibit/display budgets, and sales material utilization budgets, all which have an impact on net sales and corporate profit.
**Organizational Context**
+ Reports to an Sr/Director Area Sales Primary Care & Specialty
+ Entry level people manager role within field sales
+ Leads on average 9 sales professionals within a sales region
**Qualifications**
**Required**
+ BA/BS degree
+ At least 4 years pharmaceutical selling experience
+ Demonstrated success across a diversity of therapeutic products consistently delivering on objectives
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Motivated, results-oriented sales professional with outstanding sales experience
+ Strong communication/interpersonal skills, along with solid facilitation and presentation skills
+ Exhibits leadership, motivational, and persuasion skills
+ Demonstrate business acumen; flexibility/adaptability
+ Proactive; takes ownership of situations and demonstrates problem solving ability
+ Ability to understand sales targeting tools/reports to prioritize opportunities
+ Proficient in MS Office Suite
+ Ability to travel over 50% of the time with some overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Participation and completion of management/leadership development or assessment program
+ At least 2 years outside sales pharmaceutical management experience
+ Strong performance in prior pharmaceutical sales & marketing roles (training, product marketing, etc.)
+ Advanced degree or continued education
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-TX-Dallas) Clinical Sales Professional, Community Specialties - Dallas East, TX2024-03-01T21:48:11-05:00https://astellascareers.jobs/AEB5BF7154B642268285C47093D9BF5A26**Clinical Sales Professional, Community Specialties – Dallas East, TX**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Dallas East, TX** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-NC-Sanford) Senior IT Systems Engineer2024-02-28T21:48:12-05:00https://astellascareers.jobs/92EA57B0E7BA4CB2BEB08A93E70523D226Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **www.astellas.com** .
**About Astellas Gene Therapies**
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
**The Role:**
This position is part of the global technologies team supporting enterprise solutions for the manufacturing in the Technologies and Manufacturing division. The position will support the enterprise applications used in manufacturing. Support will include Maintenance and Enhancement (M&E) for manufacturing data information management systems, such as Aveva PI, and systems used in the integration of equipment with enterprise data management systems, such as Kepware. This position is hybrid, requiring occasional site visits. The successful candidate will be a self-starter that can work with a team or independently. The position will respond to requests and support tickets from the Manufacturing and Automation groups. They will take part in projects supporting manufacturing data solutions.
**Responsibilities:**
+ Provide advanced technical support for manufacturing data management applications and related IT systems, level 3 support.
+ Responsible for administering and maintaining applications and associated platforms, assisting users, and managing requests and incidents.
+ Work with third party vendors/partners to troubleshoot access issues or other application problems.
+ Work with business units to identify, prioritize, and resolve issues impacting business users and processes associated with manufacturing enterprise applications.
+ Assigned new project work implementing and deploying applications or processes as needed.
+ Participate in change control within operations of OT (operational technology) environment.
+ Perform system administration on multiple core IT/OT platforms as trained/required (Microsoft terminal services, MS SQL, IIS)
+ Troubleshoot system outages and other issues impacting systems and users.
+ Provide documentation for the preparation, deployment, procedures, and design of manufacturing data management solutions.
+ Assist in validation of manufacturing data management solutions, draft and execute test protocols, provide technical oversight of validation documentation.
+ Interrupt user requirements and provide recommendations on technical solutions to meet business demand.
+ Work schedule includes 'out of normal' work hours for application support & maintenance.
**Organizational Context:**
This position is a technical and team leadership position reporting to Director in TBIM supporting Technology and Manufacturing across Astellas enterprise.
**Required Qualifications:**
+ BS/BA degree in engineering, information systems or equivalent with a combination of education/work experience.
+ 6+ years of relevant IT or IS environments and solutions, in an administrator or technical expert role.
+ 6+ years’ experience with Windows platforms supporting enterprise applications.
+ 4+ years of supporting IT or IS in a biotechnology or pharmaceutical manufacturing environment.
+ 3+ years of supporting Aveva PI (previously known as OSISoft PI) system.
+ 3+ years’ experience supporting Microsoft SQL server
+ Demonstrated experience supporting manufacturing IT systems in a GMP environment.
+ Strong technical writing and oral communication skills.
+ Proven and successful experience in a mid-size corporate environment, strong collaborator in a team atmosphere, thrives on new challenges, and has a demonstrated history successfully executing technology solutions for business challenges.
**Preferred Qualifications:**
+ 2+ years’ experience supporting Kepware.
+ 1+ year Experience supporting digital transformation of bio-manufacturing site.
+ Experience supporting IT solutions in medium to large biologics manufacturing company.
+ Hands on experience integrating manufacturing data with enterprise data solution.
+ Experience with analytics tools such as Power BI, Tableau, Qlik Sense, ….
**Working Conditions:**
+ This position will be hybrid, with occasional onsite as required, will require less than 10% travel.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Technology Business Information Management
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Executive Director, Medical Lead, Immuno-Oncology Clinical Development2024-02-26T10:48:16-05:00https://astellascareers.jobs/E0D98048E2904B61B28E481FAF90943226Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
+ Accountable and responsible for establishing and overseeing implementation of a global medical development plan on a large complex late-phase project or on a group of complex earlier phases projects.
+ Responsible for people leadership of direct reporting medical leads including, supervising and coordinating their project activities.
+ Influential as a disease area expert both internal and external to Astellas.
+ Ensures a seamless transition from exploratory studies (phase 1-2) to phase 3 registrational studies.
+ Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
+ Responsible for the medical leadership through interface with research, regulatory authorities and the commercial organization
+ Provides medical leadership on the Global Project Team and chairs the Global Medical Team meetings.
+ Supports other projects as required.
+ Business requirements may include the need to provide leadership to the TA and to medical leads on various projects.
+ Position may require representing the company in negotiations on clinical studies with alliance partnerships, meetings with regulatory authorities and meetings with medical expert or industry groups.
**Essential Job Responsibilities:**
+ Accountable and responsible for design and final recommendations in clinical development plan for their drug (s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.
+ Leads the global medical team(s) to design, implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval.
+ Leads APGD medical programs when required as part of post marketing requirements.
+ Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Global Development Project Leader (GDPL)).
+ Acquires publicly available knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
+ Negotiates milestones and ensures clinical development objectives are met (in conjunction with Global Project Development Leader).
+ Plans for resources required both within the Medical Sciences organization and in conjunction with the Global Development Project Lead (GDPL) and the Global Development Operations Lead (GDOL) to accomplish the objectives in a timely and resource-efficient fashion. This includes the number of employees and contractors needed.
+ Responsible, in collaboration with Clinical Sciences, for developing, recommending and adhering to the clinical development budget.
+ Motivates and inspires global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Global Project Development Leader).
+ Serves as the Medical Sciences representative at some or most meetings with regulatory agencies worldwide as needed to support product development.
+ Informs VP Global Medical Science and TA Head of the regulatory activities and meetings and solicits participation of the VP Global Medical Science TA Head as needed for major regulatory authority interaction.
+ Contributes to Global Project Team meetings.
+ Responsible for keeping GDPL, other project physicians, VP Global Medical Science and TA Head informed of clinical progress and any critical medical issues and especially the emerging safety profile.
+ Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Vice President Global Medical Science and TA Head.
+ Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
+ May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans.
+ Presents to senior management and external audiences various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans.
+ Incorporates Health Economics Outcomes Research requirements into protocol design as appropriate.
+ May have responsibility to manage or mentor specific therapeutic area/sub-group within the Global Medical Science function through successful recruitment and retention of a high performing team and individual contributors. May have responsibility to manage the development and deployment of resources, while ensuring optimal oversight and supervision to ensure technical, leadership and team membership skills are maintained. If not directly managing other medical directors, serves as a mentor and works with senior line management to provide feedback and input to career development of junior medical staff.
**Quantitative Dimensions:**
+ Works with a number of Medical Directors across global sites and may have one or more Medical Directors, employees or study physician contractors, reporting directly into this position.
+ Budget: allocated to the Global Project Team budget.
+ Responsible for decisions and advice in scientific, clinical and/or technical areas that can impact development timelines/regulatory review periods/acceptance and create significant delay or additional costs.
**Organizational Context:**
+ Reports to Sr. Vice President Global Medical Science-Oncology.
+ Has direct or indirect supervisor responsibilities for other physicians assigned to the project(s).
+ Matrixed relationship to colleagues on the Global Project Team, Clinical Operations, Statistics, Regulatory Affairs, Clinical Pharmacology and Medical Affairs.
+ Collaborates with the APGD Global Development Project Leaders of the Global Project Team.
+ Accountable for integrating medical aspects of a project with the Asia Development colleagues and with colleagues running country specific registrational studies.
**Qualifications**
**Required**
+ Medical Degree (MD) or medically qualified with post graduate qualification and specialization in the appropriate specific therapeutic area/or one of the groups preferred.
+ At least 7 years of drug development experience specifically in human drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research (NCI, NIH, Academic Research groups etc.)
+ Proven record of being a successful medical leader and a study clinician.
+ Experience managing drug development programs.
+ Experience designing, implementing, conducting and reporting clinical studies, to produce both timely and high-quality data.
+ Experience managing and leading.
+ Proven ability to deliver results in a matrixed management environment.
**Preferred**
+ At least 3 years managing Medical Scientists and/or Medical Leads
+ Prior experience in clinical development of cellular-based therapies
+ Prior experience in medical leadership of regulatory fillings globally
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Category Therapeutic Area - Oncology, Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Senior Manager Biostatistics2024-02-23T10:45:19-05:00https://astellascareers.jobs/9EE03CA02A2841D2AC3AE096B476C82926Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
Member of cross-functional teams, the primary purpose of the Senior Manager is to act independently as Study Statistician / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for routine works in an established area (clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project). The position can also act as a Senior Methodology statistician independently validating the execution of complex common techniques, offering training/consulting to other statisticians, or researching solutions for novel situations.
The position is expected to understand when to seek Global Statistical Lead (GSTATL) and/or line management intervention to ensure successful outcome with respect to resource requirements or key strategic functional issues. Under guidance, this position may act as GSTATL, or represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders, HTA or conferences.
**Essential Job Responsibilities - Astellas is looking for diverse talents, self-motivated and eager to make a difference for the patients, therefore responsibilities listed below are characteristic of the type and level of work; not all are expected to be carried out**
+ Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers analyses
+ Translates scientific questions into statistical terms and is responsible for the quality and timeliness of corresponding statistical deliverables
+ Independently provides statistical advice related to study design, selection of endpoints, population, PK/PD or biomarkers for routine studies.
+ Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data)
+ Under the supervision of an experienced statistician, may support more complex studies or asset level analyses (i.e integrated summaries, regulatory, payer dossier and publications)
+ Personal development / Collaboration
+ Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).
+ Collaborates and communicates effectively with the other Data Science functions; in particular the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables.
+ Is responsible to develop a reliable network of academics, regulators and industry peers as well as investigate and share new statistical methodology.
**Organizational Context:**
Part of the Data Science Division (DS), Statistical & Real World Data Science (SRS) is a global, diverse, comprehensive and inclusive group of quantitative scientists who design Astellas’ development programs to allow data-driven decision-making. From candidate nomination through to commercialization and in close partnership with the Primary Focus Divisions, Medical Affairs and Early Development, SRS is accountable for all statistical aspects globally.
Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.
+ This position reports to a Director, Sr. Director or Executive Director.
+ This position is an individual contributor role.
+ This position is a hybrid position.
+ This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations or Exploratory statistics. This position is a member of the asset, study or other similar deliverable teams and closely collaborates cross functionally inside and outside Data Science
**Qualifications:**
**Required**
+ PhD or M.S in Biostatistics, Statistics or related scientific field
+ 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
+ Good knowledge and skills in SAS required, knowledge of R preferred
+ Good understanding of medical literature, clinical, regulatory, and commercial landscape
+ Ability to understand, implement, and explain complex statistical methodology
**Preferred**
+ Understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems)
+ Understanding of and experience with pharmaceutical datasets, statistical methodology, P,V and NIPASS from data identification landscaping, etc.; Understanding of how to transform research objectives into study design, regulatory publications, and abstracts
+ Working knowledge of pharmaceutical vendors/CROs and how they are used to execute on Data Science activities
+ Understanding of the DS lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization process, etc.)
+ Understanding of statistical principles, methodology and algorithms (including analyzing and interpreting data in a research environment)
+ Understanding of how data is being used and applied (e.g., models), what DS is doing across different activities for a product, and how DS is building something bulletproof from an evidence perspective
+ Hands-on programming experience within one or more statistical/data science programming languages (e.g., R, SAS, or Python) – including data manipulation and analysis of a wide array of data sources/types
+ Understanding of and experience with how to read, interpret, and communicate scientific concepts/data; Understanding of observational methods
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Statistical & RWD Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Manufacturing Associate II2024-02-16T21:48:11-05:00https://astellascareers.jobs/926D8660F98B41E5A835DACF765AA38A26**Manufacturing Associate II**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Manufacturing Associate II** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**
**Purpose:**
The Associate II will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
**Essential Job Responsibilities:**
+ Perform all manufacturing operations under cGMP/ISO requirements
+ Display understanding of Downstream process theory (e.g., tangential flow filtration, chromatography) equipment operation, and aseptic processing
+ Assist with the installation, commissioning, and validation of equipment within single use facility
+ Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
+ Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
+ Maintain a high level of quality and compliance with regards to all aspects of manufacturing
+ Assist/write SOPs (standard operating procedures), batch records, and other GMP documentation
+ Display ability to identify and escalate potential GMP issues, as required
+ Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
+ Assist in the evaluation and incorporation of new technologies
**Quantitative Dimensions:**
The Associate II will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.
**Organizational Context:**
The Associate II will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene and Cell Therapies and the Astellas organization.
**Qualifications:**
**Required:**
+ BS / BA in Chemical/ Biological Engineering or Life Sciences or Associates Degree in Science or related field with 1+ years of industry experience or H.S. diploma with 2+ industry experience
+ Experience in maintaining detailed records and ability to assist in document revisions
+ Experience in cell culture with excellent aseptic technique
+ Strong skill on biological laboratory math
+ Understanding of cGMPS as related to commercial and clinical operations
+ Strong communicator with ability to work effectively both independently and as part of a team
+ Developing problem-solving skills
+ Strong computer skills including MS Office (Word, Excel) and proven ability to establish and maintain effective working relationships with team members and managers
+ Models our Core Values: Be Bold, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Will support and demonstrate quality standards to ensure data of highest quality and will be expected to perform other duties and/or special projects, as assigned
**Preferred:**
+ BioWork Certification or related type certification are a plus along with technical understanding of a biotech manufacturing facility
+ Knowledge of protein purification and technique
+ Experience with single-use technologies
+ Understanding of FDA regulations
+ Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
+ Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts
+ Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
**Working Conditions:**
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, regular reaching over head activities, and independent mobility to lift to 25lbs
+ This is an on-site role working in a cGMP regulated manufacturing facility
+ On occasion, this role may travel to other Astellas Gene and Cell Therapiesmanufacturing facilities (0-5%)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-TD**
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Senior Manager, Omnichannel Analytics2024-02-15T10:45:27-05:00https://astellascareers.jobs/AF5B1F26899E4A84B0D62B0BA9B3C83426Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Sr. Manager, Omnichannel Analytics plays a critical role in the Medical Specialties Brand Analytics, Omnichannel Analytics & Reporting team and will be responsible for measuring the performance of promotional channels, generating insights and uncovering opportunities to help commercial brand teams be efficient and effective with promotional activities and content.
Additionally, the Sr. Manager will be a “go-to” for the commercial brand teams for deep-dive / ad-hoc analyses and new channel reporting needs assessment (in partnership with the Reporting team).
This position will work collaboratively with partners such as global/regional commercial brand teams/marketing, global/regional Commercial Insights teams, Omnichannel Strategy & Operations, and Information Systems team and will contribute to data/metrics harmonization and insights sharing.
**Essential Job Responsibilities:**
+ Develop and execute on promotional analytics measurement plans.
+ Analyze promotional data to extract actionable insights using various analytics techniques.
+ Identify and recommend promotional tactic optimization opportunities to global/regional brand teams and Omnichannel Operations stakeholders to drive efficiency and effectiveness of investments.
+ Work closely with the Global and Commercial Division Commercial Insights leads, Omnichannel Operations team, Global Brand Directors and Affiliate Brand Managers to socialize insights from the channel/promotional analyses, to provide guidance on how to optimally leverage reporting dashboards for performance assessment and opportunities discovery, to support ad-hoc requests, and to assess emerging business needs/reporting requirements.
+ Provide consulting to the key stakeholders in the campaign design/requirements gathering phase to ensure objectives are clearly defined and can be measured, content assets are properly tagged, and the campaign data is properly sourced to ensure integrity of the measurement.
+ Contribute to various commercial analytics projects as needed. Examples include Customer Segmentation, Promotional Mix Analysis, etc.
+ Co-develop Omnichannel Analytics frameworks, and continuously look for ways to improve and innovate methodologies / processes.
+ Evaluate and help evolve training support required to uplift capabilities in the use of analytics, working closely with the Advanced Analytics, Reporting and Omnichannel Operations teams. Similarly, contribute to plans for harmonized improvement across the commercial organization, addressing with tailored solutions as required.
+ Manage third party providers on as needed basis and ensure deliverables fully meet contractual obligations and are of highest caliber.
+ Embed an Ethics and Compliance culture and Integrity in Action by proactively addressing non-compliance.
**Organizational Context:**
+ Scope of responsibility will be to support US brand with respect to consumer omnichannel analytics, includes working with agencies and cross-functional internal stakeholders - e.g., brand team, Omnichannel Strategy & Operations team, Brand analytics team, Market Research team, etc.
+ Internal Stakeholders: Brand Marketing, Omnichannel strategy and operations, Brand Analytics, DAT, IS
+ External Stakeholders: Media Agencies
**Qualifications**
**Required:**
+ Bachelor’s degree
+ 6+ years of commercial experience in the pharmaceutical industry
+ 3-5+ years of statistical analysis and modeling experience within complex analytical projects (e.g., Multivariate Analysis, Clustering, ML techniques)
+ Proficiency with SQL, SAS and/or R, MS Excel and Power Point
+ Experience working with Google Analytics or Adobe Analytics
+ Experience with visualization tools like Qlik View/Qlik Sense and/or Tableau
+ Experience in KPI and diagnostic metrics development
+ Experience in promotional analytics: HCP non-personal and Consumer (US Only)
+ Experience in presenting business insights and providing recommendations
+ Strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Excellent verbal/written communication skills, attention to details, and the ability to multi-task.
+ Excellent organizational, planning and project management skills and ability to effectively manage cross-functional projects of moderate complexity in a multi-cultural context, including vendor management, regulatory & legal compliance, etc.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Ability to act with a sense of urgency while being responsive to changing business priorities.
+ Ability to travel 10-20%
**Preferred:**
+ S. in Statistics or Economics or other quantitative discipline is preferred, or MBA with Marketing Analytics, Decision Science, or Analytical Finance Concentration
+ Experience working with global partners
+ Research design experience
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Director, Rest of World Regulatory Labeling2024-02-12T17:48:48-05:00https://astellascareers.jobs/75045EF9A5F647BF80F17C3412D1775F26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Director ROW Labeling Lead will report to the Executive Director, CCDS and Labeling and sit on the labeling leadership team. In collaboration with strategic regulatory, this position will be responsible for regulatory leadership and support (both technical and operational) in the area of CCDS and product labeling for the Rest of World (ROW) Established and International market products in all primary focus areas. This will include new products and life cycle management of existing portfolio. This position will function as a ROW Labeling Lead for Established and International market products and will be responsible for all aspects of labeling development including creating, updating and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will have the responsibility of the ROW Labeling Lead, providing oversight to other Regulatory personnel including regional implementation leads who are responsible for developing or managing labeling content and ensure consistency to reference member state (RMS) labels as appropriate. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.
**Essential Job Responsibilities:**
This position will function as a ROW Labeling Lead for ROW Established and International products in all primary focus areas and will be responsible for all aspects of labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.
This position will also act as the ROW Labeling Lead providing oversight to other Regulatory personnel including regional implementation leads who are responsible for developing or managing labeling content and ensure consistency to RMS labels as appropriate. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. The position will understand and incorporate all key labeling guidance’s in established and international markets, into labeling strategies for those regions.
This position will participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. This position will assess impact of new labeling regulations and implement appropriate changes as well as lead development of company policy and position on draft regulations and guidance. This position will interact cross-functionally with members of RA, asset team, commercial, legal, safety, medical and others.
Key responsibilities include ROW labeling development and implementation, across Astellas products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling documents.
**Quantitative Dimensions:**
This position will have direct impact on the implementation of new labels and changes of CCDS, and labeling, management/coordination of regional strategies of local labeling regarding implementation of CCDS updates, and labeling compliance for all Astellas marketed products in the Established and International market regions. This position will have impact on the successful registration of new products, indications and line extensions.
**Organizational Context:**
This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Medical Affairs, and affiliates members). The position reports to the Executive Director, CCDS and Labeling, Regulatory Affairs. The individual may have direct reports at the Associate Director and Manager levels.
**Qualifications:**
**Required**
+ Bachelor's degree (preferably in a life sciences field) with preference to higher degree.
+ Relevant experience in Regulatory Affairs in the area of labeling development and review for prescription pharmaceuticals or similarly regulated industry required (10 + year of relevant experience).
+ Excellent planning, organizational, analytical, problem-solving, and decision-making skills.
+ Ability to lead and motivate others.
+ Ability to drive projects to completion.
+ Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging.
+ Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.
+ Possesses excellent written and verbal communication skills.
+ Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.
**Preferred**
+ Advanced degree (e.g., Masters, PhD, etc.,) Scientific knowledge in chemistry, general biological/physical science
+ Ability to apply that knowledge to regulatory issues and product development having technical complexity.
+ Proficiency in a second language is a plus.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Category Medical Specialities TA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Boston) Clinical Sales Professional, Community Specialties – Boston, MA2024-02-09T21:48:12-05:00https://astellascareers.jobs/2D422EC979A246758D401AD9B8777FB826**Clinical Sales Professional, Community Specialties – Boston, MA**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Boston, MA** area **.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Associate Director Clinical Data Performance2024-02-06T17:53:40-05:00https://astellascareers.jobs/19485C746FD24142B59A43681E9CAEB126Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
Medical Development Strategy & Operations (MDSO) is a leader in aligning functions across M&D organizations in areas via strategic planning, digital excellence, reporting and analytics and benchmarking, to support the execution of the business strategy of the portfolio across M&D. As the Associate Director, of Reporting and Analytics, this role will be accountable for leading development and execution of reporting, metrics, Development of cross functional stakeholder engagement strategies for maintaining data integrity and aligned process, while delivering data visualization and analytics of operational data through collaborative partnerships across M&D.
This position will be responsible for leading the delivery of reliable, actionable data to internal customers and transform operational data, from either internal or external sources, into outcomes to answer the right question at the right time with the right data. The position will be responsible to develop role based and intuitive strategies for reporting on projects and product portfolio to project teams, functions, governance, and external consortiums, as appropriate.
The position will work to collaborate on new enterprise and organizational data governance models to ensure data are consistently utilized in an appropriate manner for reporting and decision-making purposes. The position will also be responsible for overseeing change requests and establishing testing plans, as applicable, for data model and interface enhancements.
The position will work through collaborative partnerships across stakeholders in MDSO and other key functions as applicable, and functional stakeholders to advise on maintenance and updates of the reports, metrics, analyses, and data models.
**Essential Job Responsibilities:**
Accountable for:
+ Leading cross-functional collaborations on the maintenance, upgrades, integrations, and releases and decommissioning of key performance indicators across the organization, delivering regular reports according to the schedule.
+ Managing the day-to-day reporting needs, guiding decisions made and leading discussions.
+ Understanding overall business requirements and providing systems, tools, and data to meet them. When enhancements are needed to meet business needs this role translates these into project specifications (in partnership with IT), wins approval for projects, and drives delivery of projects in partnership with IT.
+ Ensuring data meets defined data governance standards either through the enterprise governance models or organizational governance models, ensuring data translations occur accurately.
+ Leads a cross-functional workstream to support business needs or resolution of complex problems with a high degree of independence.
+ Managing and triaging requests for new reports/visualizations and change requests, as assigned, and execute any testing plans needed for system/tool improvement and/or implementation.
+ Collaborating and negotiating with stakeholders, including project teams, functions and governance, to ensure the implementation and use of a streamlined “suite” of reports for decision-making.
+ Leveraging drug development knowledge, business relationship mgmt. and cross-functional partnerships to anticipate changes needed to reports, metrics, analyses, and data models.
+ Overseeing quality review process to ensure changes made in the reports and data models are reflective of and consistent with agreed upon approach and within defined information management governance standards.
+ Developing and maintaining effective collaborations with key stakeholders and functions, as well as of relevant external stakeholders, including system vendors.
+ Managing as a peer leader within the organization and actively participate to ensure success of the strategic objectives.
**Quantitative Dimensions:**
+ Responsible for evaluating opportunities to improve project and portfolio analytics and reporting to facilitate decision-making for the stakeholders supported by the analytics and reporting tools.
+ Responsible for executing and maintaining excellence in reporting and analytics with the right data at the right time to answer the right question.
+ Responsible for budget and timelines associated with assigned reporting initiatives.
+ May provide oversight and management of vendors or contractors working on a project, as applicable.
**Organizational Context:**
+ The position reports to the Head of Reporting and Analytics.
+ The position may oversee internal and outsourced support staff.
+ The position will work closely with other functions within MDSO/IS to support any gaps or improvements needed in the data model or reporting procedures for the system(s) assigned.
+ The position works cross-functionally with other Astellas groups to develop and implement excellence in project & product portfolio analytics and reporting.
**Required**
+ BA/BS.
+ Minimum 10 years in the pharmaceutical industry and/or management consulting group focused on R&D or clinical operations, with minimum 4 years in the drug development setting.
+ Experience in use of enterprise-wide data warehousing options/opportunities and reporting tools/systems, as a business user not technical/IT user, to facilitate and support the analytical and reporting capabilities for operational data.
+ Strong knowledge of tools used by pharmaceutical industry to support collection of business operations data, such as CTMS, SAP, Planisware, etc.
+ Demonstrated knowledge of the global drug development process and business processes and procedures in clinical drug development, including portfolio planning, clinical trial management, cost, staffing, resource management and/or time tracking areas.
+ Demonstrated ability to work with stakeholders to define and understand requirements.
+ Excellent oral and written communication and presentation skills in English, with an ability to interact at all levels of personnel.
+ Experience with establishing standards in support of clinical and business operations systems, especially as they impact and influence multiple departments and levels of management.
+ Strong and effective strategic thinker and problem solver with high degree of emotional intelligence, with the ability to both recognize and anticipate problems.
+ Ability to both recognize and anticipate problems. Possess the ability to translate solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.
+ Demonstrated ability to effectively build business relationships and influence without authority as part of a matrix organization.
+ Demonstrated ability to prioritize multiple projects efficiently.
+ May require up to 10% international travel.
**Preferred**
+ Minimum 3-5 years of people/project management experience, preferable in a highly matrixed, multicultural global setting.
+ Understanding of financial and resourcing planning systems and/or processes.
+ Demonstrated ability to communicate effectively with functional leaders and negotiate solutions in a matrix environment.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Category Operations, Insights & Data Intelligence
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-FL-Tampa) Clinical Sales Professional, Community Specialties - Tampa, FL2024-01-26T17:49:31-05:00https://astellascareers.jobs/4241F3D1FFEE44D09EC8905FEA540D7B26**Clinical Sales Professional, Community Specialties – Tampa, FL**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Tampa, FL.**
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Marketing Operations Manager2024-01-25T17:53:20-05:00https://astellascareers.jobs/6460EB2A601946F79FF7029F2A45E98626Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Rx+ Business Accelerator Project Manager position will be fully dedicated to BAP03 (Image Guided Precision Surgery) within Astellas RX+ Business Accelerator.
The position will lead and drive execution of identified projects to support launch readiness and commercialization of the surgical related drug as determined by the Global Brand Lead and Business Producer.
This position will collaborate with team members, internal cross-functional stakeholders and external partners globally.
**Essential Job Responsibilities:**
Lead processes for assigned BAP03 initiatives determined by Global Brand & Business Producer as follows:
+ Identify operating mechanisms and processes including but not limited to supply chain, market research approval & agency management to support commercial teams throughout the lifecycle management process.
+ Track and manage identified project initiatives such as key milestones & timelines financial and budget forecasting reconciliation, proposed annual plans and external disclosures.
+ Manage cadence of cross-functional stakeholder meetings including outlining key commercial risks and proposed actions.
+ Support new initiatives to facilitate expansion of BAP03 including portfolio expansion activities.
+ Perform and support day to day administrative and logistical tasks in target launch markets.
+ Drive effective and efficient communication across internal stakeholders and external partners.
**Quantitative Dimensions:**
+ Track and update BAP03 project status and corresponding budget on a monthly basis. Manage facilitation of key meeting cadence including monthly program updates, Global Product Strategy Team and portfolio expansion meetings (meeting coordination, summary and actions).
+ Identifies and implements Astellas operational processes to support progression through key commercial activities and launch readiness in order to achieve projected sales forecast as determined by Global Brand Lead.
+ Identify and collaborate with internal stakeholders to define new operating mechanisms where applicable.
+ Serves a point of contact for external agency management and overall approval process of associated projects.
**Organizational Context:**
+ Position reports on solid-line basis to BAP03 Global Brand Lead and dotted line to Business Producer
+ Position collaborates & communicates with BAP03 direct and cross-functional team members
+ Position collaborates with colleagues in RX+ BA and relevant internal stakeholders
**Qualifications:**
**Required**
+ Bachelor’s degree required
+ Budget management with general finance and/or accounting experience
+ Experience with new product development and/or product launches
+ Understanding of commercial pre-launch activities and associated operating functions /mechanisms throughout the lifecycle management process
+ Strong project management skills
+ Experience leading and/or working with global based teams
+ Proactive communication skills & ability to influence multiple stakeholders
+ Ability to work with sense of speed.
+ Respect diversity and cultural difference.
+ Fluent in business English
+ 5 years’ experience in pharmaceutical and/or medical device
**Preferred**
+ Project management experience in both launched and new product development
+ Financial acumen associated with NPV analysis
+ Experience collaborating with external parties for joint commercialization
+ Experience in implementing complex operations in a global organization
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Rx+ Commercial
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Medical Director Oncology2024-01-25T17:53:20-05:00https://astellascareers.jobs/8B44FAE72EAE49969341DFD74748823126**Medical Director Oncology, Medical Affairs**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas is announcing a **Medical Director Oncology, Medical Affairs, United States (MA-US)** opportunity in Northbrook, IL. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose & Scope:**
The Medical Director Oncology, Medical Affairs, United States (MA-US), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA).
The Medical Director is responsible for:
+ development of overall scientific and medical strategy for assigned product(s)
+ creation and management of internal product/TA strategy and training
+ strategic oversight and execution of data generation activities and other MA-US tactics
+ review and endorsement of, and in some cases creation of scientific exchange materials, product launch planning/operations, and strategic congress planning, including collection and assessment of external medical insights to shape medical strategies
+ representation of the US region within the Core Medical Team (CMT)
+ collaboration with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT), if applicable, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the region
+ assessment of external medical environment perspectives and informing of medical strategies, including global strategies.
**Essential Job Responsibilities:**
+ Lead the development and execution of solid strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP)
+ Accountable for oversight and execution of MA-sponsored clinical studies, as applicable
+ Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy
+ Align with peer leaders in the Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business
+ Demonstrate ability to collaborate and lead within matrix product/TA teams across multiple disciplines
+ Represent MA-US on the relevant CMT, including representation of all regional needs and activities and timely execution of the CMP tactics
+ Provide medical expertise and approval of promotional materials
+ Provide medical expertise and approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.
+ Review and approve all standard and custom Medical Information response letters
+ Initiate and support medical advisory boards within area of responsibility to understand and shape medical strategies
+ Partner with medical science liaison (MSL) team in the field, effectively translating insights into regional and global strategy
+ Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable
+ Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee if applicable
+ Provide medical expertise related to new product licensing and acquisition opportunities for the US
+ Foster a culture of 100% compliance and embody One Astellas and the Astellas Way
**Quantitative Dimensions:**
The Medical Director provides medical and scientific guidance for one or more products within the TA including accountability for MA-US product/TA strategies and execution. The Medical Director is part of a high performing medical team with direct budget responsibilities of to $10M annually, including 5-10 data generation projects and 10 medical tools annually. The results produced by the Medical Director must be scientifically sound and in compliance with applicable regulations. The Medical Director is accountable for CMP deliverables within timelines and budget and will demonstrate solid leadership and executive presence with both internal and external executive leaders.
**Qualifications:**
**Required:**
+ Medical Degree (MD)
+ Minimum 3-5 years clinical experience beyond medical school
+ Minimum 2 years Medical Affairs relevant experience within the pharmaceutical industry, or minimum 3 years clinical or academic experience after residency training
+ Experience in the US
+ Experience in working in matrix organization collaborating with medical, clinical, regulatory, health economic & outcome research, epidemiology, medical information, commercial and other organizational partners to deliver results
+ Solid scientific analytical and problem-solving skills, strategic capabilities, project management and planning and organizational skills
+ Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations
+ Ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs
+ Ability to collaborate within matrix structured product team across multiple disciplines
+ Ability to effectively engage both internal and external stakeholders, customers and collaboration partners.
+ Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g., Commercial).
+ Fluent in written and verbal English
+ Approximately 20% travel required
**Preferred**
+ Minimum 2 years Medical Affairs relevant experience within the pharmaceutical industry
+ Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred
+ Board Certified in relevant therapeutic area
+ Active medical license
+ Experience in medical research
+ Extensive knowledge of US healthcare delivery systems (e.g., accountable care, managed care, pharmacy benefit management, government [Medicare, Medicaid]) and solid understanding of policy issues)
+ Demonstrated strong interpersonal relationship and collaboration skills working within cross- functional executive leadership teams
+ Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada, ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs
**Benefits**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
*LI-CH1
Category Medical Affairs - USA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(CAN-ON-Markham) Associate Biostatistics Director2024-01-23T17:53:28-05:00https://astellascareers.jobs/DD3C1CEEBFC24C5087A39674FC8E7C7126Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Markham, Ontario. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Associate Biostatistics Director acts as fully independent global statistical lead, representing Data Science in Core Teams (CMT or Development Core Team). May be responsible for one or for multiple global or local drug projects. Leads large and/or complex projects, interacts with regulatory authorities (Payers, HTAs, FDA, PMDA, EMA, etc.) and key opinion leaders, supervises other statisticians providing support to the projects and is accountable for the statistical soundness of ALL statistical input and deliverables for the assigned projects. Provides consultancy to other project teams and other statistical leads in areas of expertise. Is expected to complete these tasks with very minimal supervision, appropriately and pro-actively seeking line management intervention where needed to ensure successful outcome, e.g. with respect to project resource requirements or key strategic functional issues.
**Essential Job Responsibilities:**
+ Participates in project teams for clinical development programs and/or lifecycle management of marketed products
+ Provides strategic statistical input to the project teams and is a major contributor to the project/product level strategy (for example, CDP, CMP, go/no go approach, OCs ).
+ Ensures that Data Science needs are reflected within the development plan and strategy across regions.
+ Provides statistical advice to study and project teams including design of studies and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.
+ Provides best in class data science support to Astellas drug development programs.
+ Ensures quality and consistency of key data science deliverables across studies. Ensures creation of maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.
+ Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
+ Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts / bodies
+ Reviews key project and study documents to ensure optimal statistical presentation and compliance.
For studies within assigned projects:
+ Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.
+ Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports, publications.
+ Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, data specifications, TLFs
+ Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
+ Provides (executive) top line reports of study results
When statistical support or programming for studies or other deliverables within assigned projects are contracted out to a CRO:
+ Contributes to vendor selection.
+ Performs vendor oversight for assigned programs: Ensures CRO is provided with details, timelines and Astellas specifications and requirements and kept up to date in case of changes. Monitors timelines, progress and specific issues, and takes action if necessary. Ensures review of the outputs created by the CRO.
Other tasks and roles may include:
+ Major contributor to cross-departmental/departmental/sectional improvement initiatives, for example: write SOPs; select, validate and implement statistical software; generate standard output or analysis methods.
+ Member or leader of external industry or professional organizations. Develops and maintain relations with leading academic institutions.
+ Perform vendor qualification / audits in collaboration with functional management
+ Investigates new statistical methodology and feeds back to department and project teams
+ Participates in due diligence activities, reviews data and advises company.
**Organizational Dimensions:**
+ The Data Science department provides statistical, biometrical and data management/warehousing expertise for all R&D projects and marketed products, encompassing Phase I-IV studies. Qualified biostatistical expertise for clinical studies and drug submissions is a regulatory requirement and carried out in accordance with international regulations (ICH, FDA, PMDA, EMA) and internal Astellas SOPs and standards. The results must be reproducible and statistically sound and are subject to internal and external inspections. Flawed statistical input to drug development projects may result in failure to achieve marketing authorization or regulatory approval delays resulting in substantial financial loss for the company.
+ Undertakes this work with minimal supervision.
**Organizational Context:**
There are 6 biostatistician levels (excluding functional management roles). This is the fourth level. Reports to Primary Focus Statistics Lead (Executive Director). Is a member of project teams. Closely collaborates with project team members (e.g. project leader, development operations lead, medical lead, HEOR, regulatory affairs, clinical pharmacology, and project management). May Lead the data science extended (project) team and deliverables teams, is a member of study teams and/or supervises other statisticians as members of study teams for studies within assigned projects. Manages to achieve successful outcome through delegation of work, coaches assigned team members within own functions. Provides guidance to / mentors less experienced statisticians.
**Qualifications:**
**Required**
+ PhD or M.S. in Biostatistics, Statistics or related scientific field
+ 6+ years (9+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
+ Experience in working on clinical project teams. Good understanding of entire drug development process - ability to see the “big picture”.
+ Experience as the independent lead statistician in regulatory interactions preferred
+ Experience with cross functional process improvement or innovation initiatives
+ Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data
+ Knowledge and skills in SAS required and knowledge of other statistical software preferred.
+ In-depth familiarity with processes and procedures in data management and programming
+ Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.
+ Ability to work in a matrix environment.
+ Proven excellent organizational, project and time management skills.
+ Leadership skills and ability to delegate appropriately and provide direction to more junior Biostatisticians.
+ Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.
+ Very good problem-solving skills.
+ Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks
+ Ability to perform under pressure
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution (RRSP for Canada)
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Statistical & RWD Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MD-Silver Spring) Clinical Sales Professional, Community Specialties - Silver Spring, MD2024-01-23T17:49:41-05:00https://astellascareers.jobs/C06A0B36314147248B439D1F9609FDCF26**Clinical Sales Professional, Community Specialties – Silver Spring, MD**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Silver Spring, MD** area.
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications**
**Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-DM**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Director, Global Clinical Pharmacology, Biologics2024-01-19T10:45:29-05:00https://astellascareers.jobs/B8BE2F51514B4E41A91252C59A8D83B626Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Director, Global Clinical Pharmacology will have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects.
The Director will be responsible for therapeutic optimization and individualization (right dose for right patient) by applying state-of-the-art scientific principles and quantitative framework (e.g. MIDD) to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, patient population, competitive landscape, background therapy, patient variability in PK and responses, formulation effects, impact of immunogenicity.
**Essential Job Responsibilities:**
+ Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing
+ Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals
+ Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results)
+ Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members
+ Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
+ Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans
+ Presentation of clinical pharmacology aspects of the global clinical development program at internal and external meetings. For example: meetings with health authorities, congresses, investigator meetings
**Quantitative Dimensions:**
+ Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
+ As a global clinical pharmacology lead (GCPL), provide the scientific lead for a cross-functional team of 15 - 25 people
+ Supervise 1-3 junior GCPLs.
+ Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
+ Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
+ Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
**Organizational Context:**
+ Reports to Clinical Pharmacology Senior Director or higher, within Early Development
+ May have direct reporting global or regional clinical pharmacologists
+ May have functional management of scientists
**Qualifications:**
**Required**
+ PhD or PharmD with fellowship in clinical pharmacology
+ At least 7 years post-graduate experience, in pharmaceutical industry.
+ Thorough knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidance
+ Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity
+ Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area
+ Knowledge of biologics drug development
+ Excellent written and oral communication skills and ability to convey complex technical information clearly
+ Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
+ Experience integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan
+ Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics
+ Curiosity and drive to ask questions, learn and keep abreast of literature
+ Confidence and ability to present to and influence senior leaders
+ Ability to critically analyze problems and provide creative/innovative solutions
+ Ability and confidence to work independently
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
Category BP Clinical Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Compliance Specialist - Second Shift2024-01-18T10:48:08-05:00https://astellascareers.jobs/E6FB48A111924722B7B5663303DA6BA026Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute of Regenerative Medicine (AIRM** ) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms --both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Compliance Specialist** opportunity at their **Astellas Institute of** **Regenerative Medicine (AIRM)** site in **Westborough, MA** . This is a **2nd shift onsite** position. Work hours will be **Monday-Friday 11:30 a.m. – 8:00 p.m.** with occasional weekends.
**Essential Job Responsibilities:**
Essential Duties and Responsibilities include, but are not limited to, the following:
+ Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting.
+ Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs.
+ May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic/international GMP regulations.
+ Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.
+ Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.
+ May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.
**Quantitative Dimensions:**
+ This position will provide a direct and positive impact on the compliance of the products, equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with the strictest international regulatory standards and meet Astellas’s uncompromising focus on Quality and Integrity.
**Organizational Context:**
+ The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality Assurance Manager, who in turn reports to the Director of Quality Assurance. Quality Assurance forms one element of the organization’s “Technical Operations” team, complementing and joined by Manufacturing, Quality Control, Engineering, Materials Management, Product Development, and Translational Development.
+ Position is organized for a work schedule of **2nd** **shift Monday – Friday 11:30 a.m. - 8:00 p.m.** In very rare instances where QA coverage is needed on weekend days or evenings, these duties will rotate within the team and be negotiated with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally runs 7 days per week.
**Required:**
+ BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
+ Working fluency the Microsoft Office productivity suite (including Excel and PowerPoint).
**Preferred:**
+ Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
+ Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.
+ Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
+ ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS1
Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Data Scientist, Ophthalmology Brand Analytics2024-01-17T21:53:05-05:00https://astellascareers.jobs/D3C499EC8D5843079F634C0E86FDB2AE26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Data Scientist, Ophthalmology Brand Analytics plays a critical role in providing valuable strategic business insight and actionable recommendations to global and priority Commercial Division/markets to support achievement of brand objectives for priority/strategic products. This position is responsible for assessing performance on an ongoing and ad hoc basis to identify new business opportunities and insights and advise key stakeholders on how best to leverage the opportunities. In addition to providing sound counseling and objective interpretation of data to the stakeholders in global and regional commercial functions.
This position will support brand-aligned analytics priorities at a global and a Commercial Division/country level. This position will work across the global and Commercial Division (CD) strategic business partners including Marketing, Health Systems, IS and co-promotion partners (if applicable).
This role will require close collaboration with Commercial Insights (CI) counterparts, when appropriate, to ensure global alignment and consistency.
**Essential Job Responsibilities:**
+ Establish strategic direction of team and ensure alignment with global objectives, Commercial Division commercial business needs and overall department objectives.
+ Collaborate with global and CD Marketing and CI GCA functions to enhance global alignment, prioritize high-impact reporting metrics around brand objectives to support better and more informed business decisions.
+ Drive strong cross-functional communication to promote brand-level knowledge sharing and integration of key learnings.
+ Conduct brand-related strategies, opportunity discovery and investment decisions with advanced analytics (examples include Customer Segmentation, Patient Adherence Analysis, HCP Network Analysis, etc) to uncover new business opportunities and insights.
+ Advise global, regional and local stakeholders and provide actionable strategic recommendations that are rooted in a strong understanding of business and brand context.
+ Inform analytical capability innovation through new methodologies/analytic techniques and in alignment with commercial data strategy.
+ Collaborate with other operational stakeholders to define, develop and maintain business rules in alignment with internal policies and business needs.
+ Identify, standardize and automate integration of critical reporting metrics and modeling tools to address brand-specific needs. Adapt current reports and metrics to support evolving business needs and opportunities; provide consultation and training on reports to ensure their use and effectiveness with users.
+ Develop, define and lead prioritized ad hoc analysis as needed to support evolving business requirements and to provide timely business insights.
+ Manage projects to include efficient resource mobilization, vendor selection, definition of scope and requirements, and achievement of timelines, budgets & deliverables.
+ Provide recommendations on various statistical modeling techniques to apply within analytical projects and mentor others on the use and application of those modeling techniques.
+ Maintain proficiency among data systems, programs, and software resources (e.g. AWS Redshift and SQL), to ensure optimal and efficient achievement of department objectives.
+ Develop comprehensive understanding of various data sources, including patient-level data, as well as their appropriate applications, to facilitate rigorous analytic process design and reliable business insights generation
**Quantitative Dimensions:**
+ Management of function within approved operating budget of up to $1MM USD.
+ Quality of strategic and operational support for assigned products including quality of the collaboration with key partners and copromote partners where applicable.
+ Accuracy, timeliness, effectiveness and ease of use of production and ad hoc performance reporting, dashboards and advanced analytics.
+ Ability to meet/exceed established key milestones related to assigned major projects.
+ Quality/timeliness of insight generation and development of actionable recommendations based on feedback from key customers and cross-functional colleagues.
**Organizational Context:**
Reports to Associate/Director, Brand Analytics.
This role is an individual contributor.
This position requires extensive collaboration across the global Commercial Insights GCA team as well as with cross-functional colleagues in global and CD Marketing, Sales, Health Systems, Finance, Sales Operations (where applicable) and IS. Additional collaboration is required with co-promotion partners (if applicable).
**Required:**
+ Bachelor’s degree in business-related field.
+ Minimum 6 years of pharmaceutical analytics, operations or related experience required that includes data analysis and reporting, or six years with Masters degree and related experience required, with demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Proficiency in coding language (e.g. SQL, SAS, R, or Python)
+ Working knowledge of various statistical modeling techniques and their application within complex analytical projects, e.g., regression modeling, promotion response modeling, ROI, natural language processing, predictive modeling, etc.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
+ Working knowledge of sales data sources, e.g., Symphony patient claims data and sub-national data, IQVIA NPA data.
**Preferred:**
+ Pharmaceutical industry experience.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence)
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense
+ Sound experience with data visualization.
+ Experience working with global partners
+ Knowledge of the global healthcare landscape including different access models
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Manufacturing Associate I - Multiple Openings2024-01-15T17:49:26-05:00https://astellascareers.jobs/9CEBE6BA4990413B936DC2470C08194626**Manufacturing Associate I**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Manufacturing Associate I** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**
**Purpose:**
The Manufacturing Associate I role will be a contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and is an entry level role in an operations environment. This includes equipment testing, SOP/batch record collaboration, and validation protocol execution support. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.
**Essential Job Responsibilities:**
+ Perform all manufacturing operations under cGMP/ISO requirements
+ Assist with the installation, commissioning, and validation of equipment within single use facility
+ Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
+ Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process; may support additional operational projects as assigned
+ Maintain a high level of quality and compliance with regards to all aspects of manufacturing
+ Maintain 100% on-time training completion in learning management systems, completing downstream on the job training curricula as required
+ Display ability to identify and escalate potential GMP issues, as required
+ Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
**Quantitative Dimensions:**
The Manufacturing Associate I will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team.
**Organizational Context:**
The Manufacturing Associate I will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene and Cell Therapies and the Astellas organization.
**Qualifications:**
**Required:**
+ 0-2 years of experience working in a GMP manufacturing environment – applicable certifications are encouraged with no industry experience
+ Strong skill on biological laboratory math
+ Knowledge of aseptic technique
+ Strong communicator with ability to work effectively both independently and as part of a team along with capacity to maintain detailed records and ability to assist in document revisions
+ Proven ability to establish and maintain effective working relationships with team members and managers.
+ Will support and demonstrate quality standards to ensure data of highest quality
+ Strong communicator with ability to work effectively both independently and as part of a team
+ Models our Core Values: Be Bold, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Will be expected to perform other duties and/or special projects, as assigned
**Preferred:**
+ BioWork Certification or related certifications along with technical understanding of a biotech manufacturing facility are a plus
+ Understanding of cGMPS as related to commercial and clinical operations
+ Capacity to learn an ability to develop technical proficiency towards the use of general MFG equipment
+ Experience with single-use technologies and understanding of FDA regulations
+ Strong computer skills including MS Office (Word, Excel)
+ Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
+ Ability to support general investigations and CAPA execution
+ Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-TD**
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MI-Grand Rapids) Regional Business Director, Great Lakes2024-01-06T02:48:13-05:00https://astellascareers.jobs/12555327B1B34EE98C010228ECB2911F26**Regional Business Director – Great Lakes**
**Position Summary:**
A field-based sales leadership role, with the priority to lead a diverse team of Territory Business Managers (TBM) focused on educating the eye care community on GA and compliantly promoting Izervay for appropriate patients in the Great Lakes Region (IL, OH, MI, IN, MO). Expected to deeply understand the business driving factors within their geographies and provide clear direction and support to their team to educate, support and influence a wide range of eye care professionals, including retinal specialists, comprehensive ophthalmologists, optometrists, and practice staff. A driven leader who is accountable and “owns the results” by leading their team like it’s their own business, balancing strategic agility and tactical execution to drive business results, while always putting patients and their needs first. This role sits on the Sales Leadership Team
**Essential Duties & Responsibilities:**
+ Motivate, coach and develop a highly motivated, engaged, and effective team of TBMs across the region
+ Build and cultivate an empowered team culture that enables high performance and collaboration
+ Oversee the implementation and execution of disease state educational awareness plans
+ Maximize revenue by driving sales performance to exceed goals, and provides sales direction and leadership to TBMs within region
+ Ensure a high level of clinical acumen, working with TBMs on customer messaging execution to deliver compliant, impactful conversations
+ Formulate and direct the activation of a regional business plan, based on contributing to national goals and integrating local TBM goals and achievements
+ Provide clear direction to TBMs on execution based on a strong link to marketing objectives and planning
+ Collaborate with and aligns on region strategy with peer functional field leadership, with accountability to achieve an optimal full office customer experience
+ Demonstrate ways to navigate complex ophthalmology referral networks within their region to make business impact
+ Perform ad-hoc special projects with cross functional input to support specific business needs requested
**Education And/Or Experience:**
+ 8+ years of experience in specialty pharmaceutical therapeutic areas within sales, experience in retina and buy and bill preferred
+ 5+ years with a proven track record of leading high performing sales teams
+ Demonstrated success within drug launches in applicable specialty markets preferred
+ Bachelor’s degree required
**Supervisory Responsibilities:** Yes
**Other Skills & Abilities:**
+ Ability to travel within the US on a regular basis, which will include overnight and weekend travel
+ Ensure that the team performs with integrity and compliance
+ Hungry for a challenge, excited by a new disease state with no established patient flow
+ Quickly find ways to build and manage / inspire a newly formed team
+ Excellent science and data driven communicator
+ Ability to provide guidance to region while empowering decisions at customer level
+ Team player and team builder, drives both individual performance and success with peers
+ Model collaboration with key field and internal partners to enable team wins, and create an impactful customer experience
Category United States Commercial
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Data Scientist, Omnichannel2023-12-20T10:48:08-05:00https://astellascareers.jobs/C42F172C2D384D7192388D8C7D69A0E026Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Data Scientist, Omnichannel plays a critical role in providing valuable strategic and tactical business insight and recommendations to Marketing, Agencies and Omnichannel Strategy & Operations (OSO) teams to support achievement of brand promotional and campaign objectives. This role will be responsible for leveraging data to drive insights, optimize customer experiences, and contribute to the overall success of our omnichannel initiatives. This position will be leading our Next Best Action initiative, which will including analyzing and measuring the promotional effectiveness of omnichannel activities and building recommendation systems using predictive models.
This position will work collaboratively with partners such as global/regional commercial brand teams/marketing, global/regional Commercial Insights teams, Omnichannel Strategy & Operations, Data Governance and Information Systems team and will contribute to data/metrics harmonization and insights sharing.
**Essential Job Responsibilities:**
+ Collaborate with key brand stakeholders and cross-functional teams to understand business objectives and measurability of campaigns and develop data-driven strategies to enhance the omnichannel experience.
+ Provide consulting to the key stakeholders in the campaign design/requirements gathering phase to ensure objectives are clearly defined and can be measured, content assets are properly tagged, and the campaign data is properly sourced to ensure integrity of the measurement.
+ Provide actionable insights through on-going reporting of all omnichannel engagements and digital tactics, including personal and non-personal promotions.
+ Develop and implement machine learning algorithms to drive personalized recommendations and targeted marketing campaigns across channels based on individual preferences and behaviors.
+ Conduct in-depth analysis of various data sources (promotional and non-promotional data) and develop predictive models to forecast HCP preferences, behavior, and overall omnichannel engagement.
+ Work with various cross-functional teams (Marketing, Media Agencies, IS and Data Engineering) to integrate and consolidate all promotional data from various sources, ensuring a unified view of customer interactions and transactions.
+ Troubleshoot data quality issues and implement solutions to maintain accurate and reliable data.
+ Develop and implement key performance indicators (KPIs) to measure the effectiveness of omnichannel initiatives.
+ Develop and implement analytics plans to support brand and portfolio level ROI optimization.
+ Be a thought leader within the organization for omnichannel analytics by proposing and implementing innovative approaches to enhance the effectiveness of omnichannel data analytics.
+ Stay abreast of industry trends, emerging technologies, and best practices in data science and omnichannel strategies.
+ Manage third party providers on an as-needed basis and ensure deliverables fully meet contractual obligations and are of highest caliber.
+ Embed an Ethics and Compliance culture and Integrity in Action by proactively addressing non-compliance.
**Quantitative Dimensions:**
+ Quality of strategic and operational support for assigned products including quality of the collaboration with key partners and copromote partners were applicable.
+ Accuracy, timeliness, effectiveness, and ease of use of production and ad hoc performance reporting, dashboards, and advanced analytics.
+ Ability to meet/exceed established key milestones related to assigned major projects.
+ Quality/timeliness of insight generation and development of actionable recommendations based on feedback from key customers and cross-functional colleagues.
+ Management of projects within approved operating budget.
**Organizational Context:**
+ Reports to the Director, Brand Analytics.
+ This position requires extensive collaboration across the global Commercial Insights GCA team. This role will also have broad global exposure as they partner with cross-functional colleagues (Marketing, Sales, Finance, Data Strategy/Data Engineering, Sales Operations (where applicable) and IS) within global functions and priority Commercial Divisions/markets. Additional collaboration is required with co-promotion partners (if applicable).
**Qualifications**
**Required:**
+ Master’s or Ph.D. in Data Science, Statistics, Computer Science, or a related field.
+ Minimum 8 years of analytics/data science experience with a focus on omnichannel analytics and demonstrated success in managing projects of increasing size and complexity.
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive proficiency with software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Strong proficiency in coding language (e.g. SQL, R and/or Python)
+ Expertise in machine learning techniques, statistical analysis, and data visualization, including classification models, promotion response modeling, predictive modeling, etc.
+ Working knowledge of omnichannel concepts and data sources, e.g., impressions/click data, web data, etc..
+ Experience working with Google Analytics or Adobe Analytics
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
**Preferred:**
+ Pharmaceutical industry experience.
+ General understanding of other Commercial Insights functions (i.e., primary/secondary market research, forecasting, competitive intelligence)
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense
+ People leadership experience
+ Experience working with global partners
+ Knowledge of the global healthcare landscape including different access models
+ Knowledge of other healthcare data sources such as patient-level data
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-CA-South San Francisco) Senior Research Associate, Discovery Bioscience2023-12-15T21:53:05-05:00https://astellascareers.jobs/07C9DEE2F53A438B91B066E3719462E626Senior Research Associate, Discovery Bioscience
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **www.astellas.com** .
**About Astellas Gene Therapies**
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
**The Role**
The Sr. Research Associate will support the Discovery Bioscience team and assist in developing and executing screening assays for the evaluation of AAV vector products. The Research Associate will be located in our South San Francisco R&D laboratories.
**Responsibilities**
+ Molecular cloning using restriction digest and Gibson assembly techniques
+ Perform cell culture work, including thawing, maintaining, expanding, cryopreserving immortalized and primary cell lines
+ Execute cell-based assays to test AAV vector candidates using routine procedures (AAV transduction, transfection, titer measurements, and cell differentiation)
+ Perform DNA, RNA, and protein isolation from mammalian cells
+ Analyze gene and protein expression through the application of a variety of techniques (RT-PCR, qPCR, digital PCR, western blot, immunofluorescence, and ELISA)
+ Collect, process, and evaluate data; Accurately document assay results and analyze data through the maintenance of an updated electronic laboratory notebook, prepare study reports, and communicate results and research progress in lab meetings as needed
+ Participate in sample management activities such as receiving, processing, storage, and shipping pre-clinical samples
+ Collaborate with other teams to acquire and aliquot vector lots, document characterization of vectors (vg titer, capsid titer, alkaline gel results)
+ Collaborate in laboratory management activities such as receiving, tracking, storage, and maintenance of laboratory reagent stock
+ Additional duties as assigned
**Required Qualifications**
+ Bachelor’s degree in Molecular Biology, Biology, Life Sciences, or a related discipline with 5+ years of experience or a Master’s Degree with 3+ years of experience in molecular and cell biology techniques.
+ Proven hands-on experience with sterile technique for handling and growing mammalian cell lines, including maintenance, cell characterization and differentiation, expansion, and banking
+ Demonstrated experience with routine molecular biology techniques (DNA/RNA/protein isolation, cDNA synthesis, RT-PCR, qPCR, digital PCR, western blot, and immunofluorescence)
+ Ability to work both independently and in a team-oriented environment to meet project goals and timelines
+ Strong written and verbal communication skills
**Preferred Qualifications**
+ Experience working with viruses, especially Adeno-Associated Virus (AAV)
+ Industry experience
**Salary Range** **:** $86,300 -$115,000 (NOTE: Final salary could be more or less, based on experience)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
\#LI-TR1
Category GT - Discovery Bioscience
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Manager, Quality Assurance Training2023-12-01T02:48:13-05:00https://astellascareers.jobs/452B1797A4B34465B19A082E2763B95726Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Quality Assurance Training Manager** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** This is an onsite position.
**Purpose:**
The Manager, Quality Assurance Training role oversees the daily operations of the GMP QA Training team. This position directly supports ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant Training program administration and classroom training.
**Essential Job Responsibilities:**
+ Manages and grows the QA Training team responsible for administration of the cGMP
+ Training program to include curricula organization and deployment, oversight of organizational training status in both local and enterprise learning management systems (LMS) and providing real-time training consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
+ Collaborates closely with all department management at the AIRM location to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
+ Partner with functional areas to conduct monitoring of training compliance status, efficiency checks, and trend results.
+ Responsible for ensuring training on documentation and training related processes and procedures are performed according to defined expectations.
+ Oversees the QA Training function. Ensures adequate systems are in place to achieve personnel training and qualification compliance with GMP quality expectations.
+ Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.
+ Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.
**Quantitative Dimensions:**
This position will regularly operate in a time-sensitive environment, with direct impact on the ability to sustain key manufacturing activities and provide value to patients in need.
**Organizational Context:**
Reports to the Senior Manager of Quality Assurance Operations. Directly manages training specialists and collaborates closely with both cross-functional and QA peers.
**Required:**
+ BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
+ Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.
+ Fluency in GMP training, document administration, and data integrity principles.
+ Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
+ Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
+ Advanced proficiency in MS Word, Excel, and PowerPoint.
**Preferred:**
+ Experience participating in, preparing for and/or hosting external regulatory audits.
+ Background or prior coursework in Cell Biology, basic biological principles, instructional design, and adult learning theory.
+ Experience with MasterControl, TrackWise, Veeva, Plateau, SuccessFactors, or other eQMS / LMS.
+ Working knowledge of MS Visio and MS Project.
+ Experience supervising and coaching subordinate leaders to achieve organizational results.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-LK**
Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Cambridge) Associate Director, Entrepreneur in Residence (EIR)2023-11-22T15:53:11-05:00https://astellascareers.jobs/9C188358DD134AF397C16CD25495649B26**Associate Director, Entrepreneur in Residence (EIR)**
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas is announcing **an Associate Director, Entrepreneur in Residence (EIR)** opportunity at their **Astellas Innovation Management (AIM)** site in **Cambridge, MA.**
**Purpose:**
EIR is aiming to bring innovation which we have not met the value before as products to deliver to patients suffering from no medical solution. EIR is responsible for establishing new Venture Unit (VU) which is aiming to create new highly competitive clinical candidates along with focused area-platform strategy in Astellas. VU is required their own clear vision, strategy and solid plan to fulfill the pipeline from internal or external research with competitive advantage. EIR leads the process of visioning, planning and networking to incubate the scientific field and finally is expected to be a VU head as a serial entrepreneur.
**Essential Job Responsibilities:**
+ Propose new VU aligned with corporate strategy to launch.
+ Establish competitive business plan for new VU including Vision, Commercial opportunity, Research plan, Resource & Budget, IP strategy and TS plan etc.
+ Take a responsibility for specific research focus in charge to plan and implement the strategy and roadmap.
+ Lead partnering process with academia or biotech to acquire essential innovation and manage collaboration with partners.
+ Build solid team through internal or external recruitment and manage scientists to implement research plan.
+ Collaborate with other global functions like Intellectual Property, Business Development, Corporate Strategy, Development or Manufacturing & Technology etc.
+ Operate the budget less than $1M in a year
+ Contribute to refine the organization and the operation in Discovery Accelerator
**Qualifications:**
**Required:**
+ PhD. in related field of science, or business with 10 years relevant pharmaceutical, biopharmaceutical or biotechnology industrial experience in R&D department, or equivalent experience.
+ MBA or business experience in startup or venture investment.
+ Understand the science in the field of synthetic biology by training to be the level to facilitate the discussion with experts in academia or biotech.
+ Use innovation to exploit opportunities available in the market and overcome any threats.
+ Mindset and Skill for visioning, strategic approach, goal oriented, sense of urgency, risk-taking and networking to be a strong leader rather than manager.
+ Communication skill with natural vertue, accountability, dedication and transparent to be supported by internal or external partners and stakeholders.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-LK
Category Discovery Accelerator
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Manager, Quality Assurance Document Control2023-11-18T02:48:12-05:00https://astellascareers.jobs/BAAA844A102F4E539B7C14512A04F8E626Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based at our Westborough, MA site. This is an onsite position.
**Purpose and Scope:**
The Manager, Quality Assurance Document Control (QADC) role oversees the daily operations of the GMP QA Document Control team. This position directly supports ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant document issuance, reconciliation, and document implementation support.
**Essential Job Responsibilities:**
+ Manages and grows the QA Document Control team responsible for administration of the cGMP Documentation program. This includes document issuance / reconciliation; SOP implementation, periodic review, and obsoletion; organization and management of critical cGMP documentation in the QA file room; and oversight of Astellas's records and information management program at the AIRM location. Provides real-time document consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
+ Collaborates closely with GMP department managers at the AIRM location to determine document needs, establish, and improve necessary document templates, and guide QADC staff to support project needs and maintain site compliance with good documentation practices and cGMP data integrity requirements.
+ Partners with functional areas to conduct periodic review of existing cGMP procedures.
+ Oversees the QA Document Control and GMP records and information management functions. Ensures adequate systems are in place to achieve and maintain records retention compliance pursuant to Astellas policies and regulatory requirements.
+ Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.
Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.
**Quantitative Dimensions:**
This position will regularly operate in a time-sensitive environment, with direct impact on the ability to sustain key manufacturing activities and provide value to patients in need.
**Organizational Context:**
Reports to the Senior Manager of Quality Assurance Operations. Directly manages training specialists and collaborates closely with both cross-functional and QA peers.
**Qualifications:**
**Required**
+ BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
+ Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.
+ Fluency in GMP documentation fundamentals, document administration, and data integrity principles.
+ Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
+ Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
+ Advanced proficiency in MS Word, Excel, and PowerPoint
**Preferred**
+ Experience participating in, preparing for, and/or hosting external regulatory audits.
+ Background or prior coursework in Cell Biology, basic biological principles, and/or Visual Basic for Applications.
+ Experience with MasterControl, TrackWise, Veeva, or other eQMS.
+ Working knowledge of MS Visio and MS Project.
+ Experience supervising and coaching subordinate leaders to achieve organizational results
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS1
Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Senior Bioprocess/Process Engineer2023-11-11T10:53:11-05:00https://astellascareers.jobs/B3964B41971740E686B5F6B02C96A4C926Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
**Astellas Institute of Regenerative Medicine (AIRM** ) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a **Senior Bioprocess/Process Engineer** opportunity at our **Astellas Institute of Regenerative Medicine (AIRM)** site in **Westborough, MA** . This is an **onsite position** .
**Purpose and Scope:**
The Senior Bioprocess/Process Engineer will be responsible for Manufacturing, Science & Technology (MSAT) activities and deliverables, and for providing technical leadership and support to expanding manufacturing process platforms and pipelines in cell/gene therapies. The position will support operations including upstream and downstream drug substance manufacturing and drug product filling. The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, Process Development, Quality Assurance, R&D, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors.
**Essential Job Responsibilities:**
+ Deliver a tech transfer and product lifecycle management program that incorporates phase appropriate requirements and expectations, improves tech transfer efficiency, and drives process optimization and cost of goods reduction.
+ Lead tech transfer discussions between sending unit (Research, Process Development, and Pilot Plant) and receiving unit (Manufacturing, QA, QC, Supply Chain, Automation, Process Engineering, and Validation).
+ Author process descriptions, engineering protocols, and technical reports. Create feasibility/gap assessments and facility fit analysis for new products and processes.
+ Drive risk assessments for new processes, process changes, and process comparability.
+ Author process comparability protocols for drug substance and drug product.
+ Own new product introduction and product phase progression change controls.
+ Manage manufacturing process sample plans (site dependent-Sanford).
+ Support audits and inspections from internal and health authority organizations. Support regulatory interactions and submissions.
+ Collect, organize, analyze, and present process data to enhance process understanding and identify improvements. Author engineering and campaign summary reports. Support process deviation investigations, root cause analysis, and CAPAs.
+ Represent MSAT and the site in various CMC meetings with Regulatory and Program Leads.
**Quantitative Dimensions:**
The Senior Bioprocess/Process Engineer will provide expertise in MSAT activities and deliverables for upstream and downstream drug substance and drug product GMP and non-GMP cell/gene therapy manufacturing. The role is expected to manage and lead at least three product lifecycles. They are responsible for staying up-to-date on technology advances and recommend new technologies that will enhance processes.
**Organizational Context:**
The Senior Bioprocess/Process Engineer will report to the Associate Director/Director, MSAT & Engineering. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.
**Qualifications:**
**Required**
+ MS in Engineering or Life Sciences with 2+ years of relevant experience or BS with 4+ years of relevant experience.
+ Experience in biologics GMP manufacturing tech transfer.
+ Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics, manufacturing operations support, and GMPs, ICH, ISPE, and BPE guidelines.
+ Familiar with QC methods for testing cell/gene therapy Critical Quality Attributes for drug substance and drug product including purity, potency, safety, identity, and physiochemical properties.
+ Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
+ Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.
+ Excellent organizational and time management skills with ability to set own priorities and strong attention to detail.
+ High degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlines.
+ Ability to think critically and demonstrated troubleshooting and problem-solving skills.
+ Experience working in cross-functional organization with ability to multitask, prioritize and be an effective and influential decision maker.
+ Demonstrate data integrity standards to ensure data of highest quality.
+ Mentor/train junior staff may manage contractors.
+ Keep current with advances in technologies, evaluate and recommend new technologies that will be useful in expanding and enhancing platform processes; coordinate and champion deployment in manufacturing as appropriate and develop and execute engineering studies.
+ As assigned, this position may be required to work during non-traditional work hours to support critical business operations.
**Preferred**
+ MS in Engineering or Life Sciences with 6+ years of relevant experience or BS with 8+ years of relevant experience.
+ Experience in cell/gene therapy GMP manufacturing, scale-up/scale-down, and tech transfer.
+ Experience with biostatistical analysis and associated software (e.g., JMP).
+ Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state.
**Working Conditions**
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
+ This is an on-site role. Working inside the cGMP regulated manufacturing facility is site dependent.
+ On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%).
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-SS1**
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) Compliance Specialist2023-11-07T21:53:13-05:00https://astellascareers.jobs/838A241193C043B4806AD4285BD07B9D26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. Astellas Institute of Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms --both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Compliance Specialist opportunity at our Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA. This is an onsite position.
**Purpose and Scope:**
This member of the Quality Assurance team will perform critical QA compliance tasks in support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients.
**Essential Job Responsibilities:**
Essential Duties and Responsibilities include, but are not limited to, the following:
+ Performs QA review of executed Manufacturing batch records, QC test records, raw material inspection records, and calibration records. Identifies and reports documentation errors and deviations from SOP or specifications in a timely manner. Tracks basic metrics on reviewed documents to support monthly reporting.
+ Assists with the Deviation and Corrective / Preventive Action (CAPA) programs, aids investigations, and may assume investigation leader status for select deviation investigations. Helps ensure that deviation records are clearly written, technically sound, and provide thorough root cause analysis a risk assessment. May assist with monthly metrics and continuous improvement opportunities for these programs.
+ May assist with the Internal Audit program for the organization, serving as an assistant auditor to help ensure all aspects of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.
+ Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.
+ Authors (or assists in authoring) new or revised standard operating procedures (SOPs) for the QA department to satisfy new compliance requirements or improve work practices.
+ May assist senior QA staff in oversight of contract manufacturing organizations (CMO), monitoring information requests, reviewing CMO work, and following up on other compliance items.
**Quantitative Dimensions**
This position will provide a direct and positive impact on the compliance of the products, equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with the strictest international regulatory standards and meet Astellas's uncompromising focus on Quality and Integrity.
**Organizational Context:**
The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality Assurance Manager, who in turn reports to the Director of Quality Assurance. Quality Assurance forms one element of the organization’s “Technical Operations” team, complementing and joined by Manufacturing, Quality Control, Engineering, Materials Management, Product Development, and Translational Development. Position is organized for a normal work schedule of Monday – Friday, day shift. In very rare instances where QA coverage is needed on weekend days or evenings, these duties will rotate within the team and be negotiated with management in advance. GMP Operations at AIRM support cell culture manufacturing platforms, which naturally run 7 days per week.
**Required**
+ BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Master's degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
+ Working fluency, the Microsoft Office productivity suite (including Excel and PowerPoint)
**Preferred**
+ Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
+ Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management.
+ Specialized knowledge of any industry-related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
+ ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
+ Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
\#LI-SS
Category Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-FL-Fort Lauderdale) Clinical Sales Professional, Community Specialties - Hollywood North, FL2023-10-18T05:46:31-04:00https://astellascareers.jobs/FC57A12524E648C1AE5EA5BC72EC6D1626**Clinical Sales Professional, Community Specialties - Hollywood North, FL**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Hollywood North, FL** area.
The Role
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
Primary Responsibilities
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
Quantitative Dimensions
This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
Organizational Context
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
Required
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
Preferred
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
\#LI-AC1
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Associate Director/Director, Biostatistics2023-10-13T06:02:16-04:00https://astellascareers.jobs/BBE2FFBA632E425C8ADCE6C95B71AFFA26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in United States or Ontario, Canada. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
The Associate Director / Director Biostatistics is a senior level statistician responsible for the supervision (Director level, in a matrix way) of other statisticians, provides statistical leadership and has a major influence on the technical capabilities of the department. This position works independently and involves the right level of participants as needed (Cross functional peers, Senior Management, Primary Focus Statistics Lead (PFSL)), effectively engaged as a matrix team member in Medical & Development (M&D). This position represents Astellas on statistical matters related to clinical data analysis or methodology at meetings with regulatory authorities, key opinion leaders and HTAs.
The Associate Director / Director Biostatistics has an extensive knowledge of his/her scientific area of responsibility; ability to ask critical scientific questions and to challenge hypotheses, designs and results interpretation. This position supports Senior Management with decision-making at the asset and portfolio level. Work has significant impact in terms of contributions to Statistics, and to other functions within Data Science, Astellas M&D and outside of the organization.
This position may act as global statistical lead (GSTATL) for a late phase or novel asset in the Cell and Gene Therapy development area, depending on relevant experience.
The Associate Director / Director Biostatistics challenges, assesses and discuss the asset strategy, supports interactions with regulatory authorities and key opinion leaders, and is accountable for the statistical soundness of all statistical input and deliverables for the assigned projects. The incumbent will demonstrate an understanding of Astellas’ priorities and uses broad to advance Astellas’ mission through high quality statistical work.
Although not a functional manager, the Associate Director / Director contributes in ensuring that Astellas is at the forefront of recruitment, training, professional development and retention of statistical personnel.
**Essential Job Responsibilities:**
+ Accountable for multiple projects, providing leadership and advising project teams and statistical leads by challenging statistical design, analysis and decision-making issues
+ Provides expert opinions, advises staff on available statistical methodologies, performs/supervises modeling and simulations, and leverages external experts to provide input to clinical development issues
+ Provides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts
+ Provides statistical leadership and consultancy to address authority requests, publication, presentation and other external sharing of results
+ Reviews key project level documents and advises other statisticians on design and methodologies
+ Contributes to or leads cross-functional or asset level improvement initiatives like development and implementation of best-in-class standards, processes and SOPs in statistics.
+ Participates in due diligence activities, reviews data and advises company
+ Remains current with cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, particularly with respect to the therapeutic area(s) of interest and signals relevant developments in a timely manner for the company.
+ Researches, creates, validates, implements and teaches complex statistical methodologies ensuring the department stays at the forefront of statistical methodologies in drug development
+ Coaches and supports statistical leads in providing best in class data science support to Astellas drug development programs.
+ Inspires and advises individuals in investigating and applying advanced statistical methods in drug development programs.
+ Challenges and influences peers and senior managers inside and outside of Data Science on best practice in their area of competence.
**Organizational Context:**
The Associate Director / Director Biostatistics is an individual contributor reporting to Primary Focus Statistics Lead (Executive Director).
With previous submission and regulatory interactions experience, the Associate Director / Director Biostatistics works on the most complex and critical projects from pre-Candidate Nomination (CN) till life cycle management impacting CN, POC, approval and post submission strategies.
Taking advantage of the matrix structure, the Associate Director / Director Biostatistics can independently contribute to the asset strategy in collaboration with the regulatory authorities and key opinion leaders and is accountable for the statistical soundness of all statistical input and deliverables for the assigned projects.
**Qualifications:**
**Required**
+ PhD or M.S in Biostatistics, Statistics or related scientific field
+ Director Level: PhD 9+ years / MS 12+ years of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas;
+ Associate Director Level: PhD 6+ years / MS 9+ years
+ 2+ years of demonstrated experience in working on global clinical studies and projects or global process and system initiatives
+ Knowledge and skills in SAS required, knowledge of R preferred
+ Experience working in an international environment and in a matrix environment.
+ Excellent understanding of submission process, previous regulatory/HTA interactions experience
+ Record of publications in clinical trials or methodological research,
+ Understand Real World Evidence, omics, digital endpoints, drug development and commercialization.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-SS
Category Statistical & RWD Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-MA-Westborough) QC Analyst II, Microbiology - (Noon-8pm shift)2023-10-10T19:02:31-04:00https://astellascareers.jobs/BC4B513A6EE945EE8CE3B6BB8C99270D26Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Westborough, MA. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
**Purpose and Scope:**
QC Analyst II, Microbiology will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program and microbial testing. QC Analyst II will be responsible for executing, review, technical writing, and training. This role is scheduled for Monday to Friday second shift (12 pm to 8 pm) supporting GMP operations.
**Essential Job Responsibilities:**
+ Perform gowning for Grade B/A manufacturing areas to collect EM samples for viable air, non-viable particulates, and surface viable samples, support manufacturing team with QC testing/EM.
+ Reviews data and documents for product testing, EM for lot release and trend reports.
+ Perform routine microbial testing of media release, products testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
+ Be an SME for microbial testing and help train new hires/associates, help with assay/instrument troubleshooting, qualification, and procedure/report writing.
+ Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
+ Perform plate reading, logbook review, and lab data documentation per GDP requirements.
+ Perform updating laboratory procedures and in data trending/summarization of the EM trend reports.
+ Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
+ Own Incident reports, deviation and OOS investigations-work with the team to find a root cause and corrective actions for out of specification results.
+ Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.
**Quantitative Dimensions:**
The QC Analyst II, Microbiology routinely interacts with Manufacturing, QC Analytical, Quality Assurance, and management for microbiological testing and special projects.
**Organizational Context:**
The QC Analyst II Microbiology will typically report to the Associate Director, QC Microbiology. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas organization.
**Qualifications:**
**Required**
+ B.S. degree in Biology/Microbiology with 3+ years or MS with 0-2 years of relevant industry experience in a QC lab.
+ Demonstrated experience of aseptic techniques and common microbiological testing.
+ Must be able to gown into cleanrooms to perform EM testing.
+ Good documentation, data organization, detail oriented, and willingness to learn.
+ Must be capable of observing and adhering to lab safety standards and procedures
+ Successfully performs routine work independently with minimal instructions
+ Excels in a fast-paced team environment and completes assigned work in timely fashion.
+ Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment
+ This role is scheduled to work during second shift (12 pm to 8 pm) on Monday to Friday and flexibility may be required to support GMP Operations.
**Preferred:**
+ Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
+ Models our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and compliance
**Working Conditions:**
+ This role frequently requires long hours of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting to 35lbs
+ Requires gowning inside the cleanroom for extended periods of time.
+ Use of gloves and mask is required to prevent exposure to biohazards and viruses.
+ This is an on-site role working in a cGMP regulated manufacturing facility.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
\#LI-TD
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-IL-Northbrook) Senior Data Scientist, Commercial Analytics2023-08-05T09:51:53-04:00https://astellascareers.jobs/DB674B39E83040B5B65618D43E38F15226Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
**Purpose:**
The Senior Data Scientist, Commercial Analytics plays a critical role in providing valuable strategic business insight and actionable recommendations to Marketing and various internal functions to support achievement of overall portfolio and brand objectives.
This hand-on position is responsible for developing and executing advanced analytics frameworks and methodologies as part of the Astellas global commercial analytics capability, in addition to providing sound counseling and objective interpretation of data to the commercial organization.
This role will require close collaboration with Commercial Insights (CI) counterparts, when appropriate, to ensure global alignment and consistency.
**Essential Job Responsibilities:**
+ Contribute to the development of data science methodologies, frameworks and best practices across customer/stakeholder archetypes.
+ Develop and implement advanced analytics models and mentor others on the use and application of those modeling techniques.
+ Support brand-related strategies, opportunity discovery and investment decisions with advanced analytics (examples include Customer Segmentation, Patient Adherence Analysis, HCP Network Analysis, etc.); inform global, regional and local brand related decisions
+ Implement marketing performance measurement processes such as Marketing Mix Optimization, brand tactics / campaign assessment ROI, etc.
+ Contribute to analytical capability innovation through new methodologies/analytic techniques and in alignment with commercial data strategy.
+ Standardize analytic processes to continuously monitor and measure performance across brands and markets.
+ Collaborate with other operational stakeholders to define, develop and maintain business rules in alignment with internal policies and business needs.
+ Develop, define and lead prioritized ad hoc analysis as needed to support evolving business requirements and to provide timely business insights.
+ Lead and manage projects to include efficient resource mobilization, vendor selection, definition of scope and requirements, and achievement of timelines, budgets & deliverables.
+ Maintain proficiency among data systems, programs, and software resources, including Microsoft Access, Excel, Cognos, and QlikView, to ensure optimal and efficient achievement of department objectives.
+ Develop comprehensive understanding of various data sources, including patient-level data, as well as their appropriate applications, to facilitate rigorous analytic process design and reliable business insights generation
**Quantitative Dimensions:**
+ Project management within approved operating budget.
+ Quality of strategic and operational support for up to assigned products or projects based on feedback from key partners and cross-functional colleagues including quality of the collaboration.
+ Accuracy, timeliness, effectiveness, and ease of use of advanced analytics based on feedback from key customers and cross-functional colleagues.
+ Ability to meet/exceed established key milestones related to assigned major projects.
+ Quality/timeliness of insight generation and development of actionable recommendations based on feedback from key customers and cross-functional colleagues.
**Organizational Context:**
+ Reports to Director, Advanced Analytics & Methodology
+ This role is an individual contributor.
**Qualifications:**
**Required:**
+ Bachelor’s degree in business-related field.
+ Minimum 6 years of pharmaceutical analytics, operations or related experience required that includes data analysis and reporting, or seven years with Master's degree and related experience required, with demonstrated success in managing related teams and projects of increasing size and complexity.
+ Recent hands-on experience with statistical modeling techniques and their application within complex analytical projects (e.g., regression/promotion response modeling, ROI, correlation coefficient, etc.).
+ Possess strong interpersonal skills with the ability to effectively interact with all levels of employees including senior management.
+ Extensive computer proficiency with desktop software in a Windows environment required including Microsoft Excel and PowerPoint.
+ Excellent skills in the following areas: organization, written and verbal communication, accuracy and personal initiative.
+ Excellent organizational, planning and project management skills with a strong attention to detail and ability to effectively manage cross-functional projects.
+ Ability to work independently in a dynamic fast-paced environment, with minimal supervision.
+ Demonstrated ability in taking initiative to proactively evaluate existing sales strategies and recommend changes, when appropriate.
+ Keen analytical mind with superior problem solving and technical skills, reflecting in-depth knowledge of various secondary databases and their limitations.
+ Sound experience with data visualization, trending/forecasting, optimal resource utilization.
**Preferred:**
+ Pharmaceutical industry experience.
+ Working knowledge of sales data sources, e.g., Symphony patient claims data and sub-national data, IQVIA NPA data.
+ Working knowledge of one or more programming languages such as SQL, SAS, and R
+ Working knowledge of one or more data visualization tools such as Excel, QlikView and QlikSense.
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**\#LI-KT1**
Category Commercial Insights
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-WV-Charleston) Clinical Sales Professional, Community Specialties2023-06-02T21:53:10-04:00https://astellascareers.jobs/906F4EB5F1194CDA9DBBE2228F711B9226Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunities in the following areas:
+ Hollywood, FL
+ New Orleans, LA
+ San Antonio, TX
+ Minneapolis, MN
+ South Florida
+ Columbus, OH
+ Murfreesboro, TN
+ Chapel Hill, NC
+ Jersey City, NJ
+ Morristown, NJ
+ Joliet, IL
+ Charleston, WV
+ Atlanta, GA
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individual's in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
**This position:**
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates and cross functional colleagues as appropriate
+ Balance's territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications**
**Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver's license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
**Salary:**
+ $69,800 - $93,000K (NOTE: Final Salary could be more or less, commensurate with experience).
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans(USA-VA-Richmond) Clinical Sales Professional, Community Specialties - Richmond, VA2023-04-14T09:51:11-04:00https://astellascareers.jobs/4EBEC027140F4A73B5B22F23873935A926**Clinical Sales Professional, Community Specialties – Richmond, VA**
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Clinical Sales Professional - Community Specialties opportunity in the **Richmond, VA** area.
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance’s territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications**
**Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver’s license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position
**\#LI-LK**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Medical Specialties Business Unit
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans