Astellas Pharma Senior Manager/Associate Director Clinical Operations 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 & Scope:
The Associate Director, Clinical Operations within Medical Operations has responsibility for strategic operational planning, oversight and/or execution of Medical Affairs data generation activities, including Astellas Sponsored Research (interventional, non-interventional, and HEOR studies) and Collaborative Research (CR). The Associate Director is responsible for working closely with key stakeholders across the region. This individual serves as an integral member of the Clinical Operations Team and provides strategic guidance on activities associated with data generation including internal/external collaborations. The Associate Director may be a people manager within Clinical Operations as applicable.
Essential Job Responsibilities:
Direct key initiatives and tactics to support Medical Operations including budgeting and planning, synopsis/protocol coordination, vendor selection and oversight, alignment of timelines and plans, etc.
Support assessment of resource needs related to data generation activities and CMP deliverables
Create and monitor reports on key performance metrics and status of data generation activities aligned with Core Medical Plans
Responsible for support of data generation processes and ensuring compliance with all applicable legal and regulatory, quality and compliance guidelines and creation/update of same as necessary
Apply best practices of GCP across multiple study types including HEOR led prospective and retrospectives studies
Lead process improvement projects for Medical Operations as needed
Engage with internal and external stakeholders concerning planning, oversight, execution and reporting of data generation activities, including but not limited to systems such as IMPACT and HELIX
Coordinate and work closely with all stakeholders involved with data generation activities including Therapeutic Area (TA), Medical Affairs Groups (Operational Excellence, Regional Medical/Clinical Operations), Advanced Informatics and Analytics (AIA), Regulatory, Legal, Ethics & Compliance, Procurement, Pharmacovigilance,
Create and facilitate study quality and compliance check process for MA data generation activities
Provide subject matter expertise in review of Process Improvement and Quality Documents relating to Medical Operations activities
Create, conduct and/or recommend training in order to maintain and/or enhance MA knowledge of appropriate data generation processes
The Associate Director responsibilities span the entire product portfolio of data generation activities within MA. The Associate Director is part of a high performing Clinical Operations team with indirect budget responsibilities of up to $15M annually, including 15-25 data generation projects annually. This includes creation, identification and tracking of budgets and metrics. The Associate Director may have direct reports or manage contract personnel., including setting performance objectives and development plans, and conducting annual performance The Associate Director is accountable for MA deliverables and will demonstrate solid leadership with both internal and external leaders. The results produced by the Associate Director must be operationally sound and in compliance with applicable regulations.
The Associate Director reports to the Sr. Director, Medical Operations or above and will work within multiple cross-collaborative project teams and have matrix responsibilities. The Associate Director will collaborate with the following colleagues:
MA: Medical Directors/RMT leads/CMT members, Health Economics & Outcomes Research Managers/Directors, Training, Project Management, Medical Science Liaisons, Operational Excellence, Regional Medical/Clinical Operations
M&D: Pharmacovigilance, Regulatory, Project Management
Advanced Informatics and Analytics (AIA)
Other: Procurement, Finance, Legal, Ethics & Compliance
External: Key External Experts, Astellas partners, and medical organizations
Minimum of a bachelor's degree in health-related sciences
Minimum of 10 years of experience with a BA or BS OR minimum of 7 years of experience with a MS OR minimum of 5 years of experience with a MD, PhD, PharmD in the pharmaceutical industry or related fields
Proven Project Management skills
Demonstrated ability to manage multiple projects and competing priorities
Demonstrated high level of competence with MS Office applications and SharePoint,
Clinical study management experience
Demonstrated knowledge and understanding of research protocols and study design
Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organization and planning skills and budget/accounting
Ability to maintain data and confidentiality
Demonstrated personnel management skills
Advanced degree in health-related clinical sciences
Solid expertise in developing synopsis and protocols
Experience with investigator sponsored research
Experience in real-world data analytics
Direct experience in working with key external experts
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
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.
Category Medical Affairs
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans