Astellas Pharma Senior Director, Global Development Project Lead (Medical Specialties) in Northbrook, Illinois
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 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 Senior Director Global Development Project Leader (GDPL) reports to the Global Therapeutic Area Head or an Executive Director GDPL and participates in the creation and execution of the Therapeutic Area Strategy for assigned programs. The Senior Director GDPL plays a leadership role in the strategic development and implementation of drug development programs for (novel) compounds that may be at any phase from early development stages (P0) through global approval across multiple indications. The Senior Director, GDPL provides strategic direction and leadership for one or multiple Astellas Development (APGD) Core teams including late stage and complex projects.
Essential Job Responsibilities:
Provides strategic direction and leadership of global development programs from P0 to NDA/MAA for assigned projects in accordance with the global therapeutic area strategy, established timelines/milestones and in accordance with all applicable regulatory standards. Responsibilities may include programs at both early and late stages of development. Provides input and leadership in development of budgets, resource estimations and allocation.
Assumes a global perspective in development of global projects and effectively collaborates with Therapeutic Area Heads, Functional Unit Heads and Functional Management to ensure Development Core Teams are effectively resourced. Establishes good working relationships and collaboration with members of the core teams and respective Functional Management (GRL, GDOL, GSTATL, GPML, GCPL, GML, PM-TA and others).
In collaboration with Core Team representatives, provides oversight and direction and is accountable for the translation of project/program level strategies into a comprehensive global development plan. Ensures successful application and incorporation of strategic input from Core Team representatives which ensures M&D development programs meet the highest level of scientific, clinical and technical excellence.
Participates in the assessment and due diligence of new chemical entities for potential in-licensing and acquisition, primarily but not exclusively within the relevant therapeutic area.
Chairs the global project team and reviews development plans for assigned projects at all milestones.
Leads preparation of PMDA/EMEA/FDA milestone meetings, such as Pre-IND, End-of- Phase II, Pre-NDA, Advisory Committees, focusing on the key strategic issues.
Provides strategic input pertaining to study objectives, including pre-clinical, CMC, and clinical development plans. Facilitates meaningful interpretation and assessment of trial data, and decision making.
Accountable for effective leadership within matrix environment for assigned projects implement and ensures key development milestones for assigned projects are met. Actively manages issues, issue escalation and proactively identifies alternative strategies in participation with Core Team representatives to develop and implement risk mitigation strategies which impact key milestones.
Defines creative approaches for enhancing product value for assigned projects by promoting brand recognition and thorough product lifecycle management for assigned projects.
Facilitates communication and information sharing across project team, other functional areas in Astellas both locally and globally. Excellent understanding of the interdependencies of the various disciplines (CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance, etc); what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
Maintains an up-to-date knowledge of global drug development regulations, good clinical practice guidelines (i.e., GCP, ICH), and compliance issues (e.g.: PhRMA guidelines).
Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, and regulatory) relevant for the execution of the job responsibilities. This includes attendance of major scientific conferences, review of published scientific medical literature, frequent meetings and discussions with key experts in the relevant therapeutic area. Develops and maintains an up-to-date knowledge base for assigned project(s) including knowledge of preclinical and early development program (as available).
Develops and maintains an up-to-date knowledge base for assigned project(s), including analysis of competitive drugs in development and marketed products. Knowledgeable about therapeutic specialty to ensure target product profile is appropriate from a scientific perspective.
Supports the Global Therapeutic Area Head in development of the knowledge and experience base within the therapeutic area(s).
Participates in the development and maintenance of effective collaborations with internal key stakeholders and functions, as well as the selection and oversight with PRSM of relevant external vendors.
With TAHs, ensures common knowledge platform by therapeutic area and molecule, performance management process for GML role.
With the Global TAH and with PRSM, DPM and IT ensures alignment with resources, budget, roles and processes associated with project planning and management.
With Clinical Pharmacology, ensures alignment at level of CDP design and content quality, role of medical monitor for phase I and POC trials.
With Commercial and Medical Affairs partners determines appropriate design of early and late phase studies to incorporate health outcomes, population modeling, etc.
The Senior Director GDPL is accountable for Astellas Development programs and their annual budget. This includes direct study costs which will vary depending on the size and stage of the clinical program as well as general costs used for program related travel, consultant fees, etc. The Senior Director GDPL is accountable and responsible for the successful development and implementation of Astellas development strategies across assigned programs and facilitating effective, efficient decision making. Delays, inadequacies in scientific, clinical and/or technical rigor can impact development timelines/regulatory review periods/acceptance and create significant delays or additional cost. Proactive identification of risks and risk mitigation strategies are essential.
The Senior Director GDPL reports to the Senior Vice President, Global Therapeutic Area Head or an Executive Director GDPL and does not have any direct reports. The Senior GDPL Director is accountable for effectively managing a multi-disciplinary group comprised of Core Team Members to meet critical development timelines. Members of the Core Team are often Associate Directors to Senior Directors (i.e. GML, GRL, GDOL, GSTAL, GMWL, GPML, GCPL and others).
Bachelor’s Degree and Minimum of ten (10) years’ experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology. An MD, PhD or PharmD is preferable. Demonstrated scientific and/or clinical expertise within assigned specialty or therapeutic area.
Demonstrated effective leadership of drug development projects across multiple program types and increasing complexity and proven track record of leading the development of at least one development candidate within a matrixed, global organization with adherence to quality, excellence and efficiency.
Experience includes leadership in more than one IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings.
Excellent communication and collaboration with team members and relevant people as well as scientists and external decision-makers worldwide.
Proven ability to develop and lead high performing, cross functional teams and effective partnership with Functional Line Management to raise and resolve team effectiveness issues.
Proven competency and ability to influence local and global regulatory, scientific and commercial stakeholders, including external agencies and Astellas development partners.
Proven ability to assimilate data, recognize key variables and analyze complex situations and demonstrated history of making quality judgments.
Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
Successful track record in education and counsel of others on Regulatory Guidance, Internal SOPs/PM concepts for assigned programs.
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 Therapeutic Area - Oncology, Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans