Associate Director, Clinical Trial Delivery Unit FSP Oversight Manager
Biogen
•$171,000 - $236,000•Hybrid
About The Position
The Associate Director, Clinical Trial Delivery Unit (CTDU) Functional Service Provider (FSP) Oversight Manager partners with the CTDU Leadership Team to drive and manage its robust FSP insourcing model. This role oversees and develops a team of FSP staff, embedding consistent, efficient processes across the function. It ensures alignment with CTDU’s key internal and external stakeholders on FSP role execution and performance to secure alignment in direction and delivery. This role also contributes to shaping the CTDU’s direction as part of the CTDU Extended Leadership Team.
Requirements
- A proven manager who can oversee FSP staff, including resource planning, training, and performance management.
- An ability to leverage comprehensive knowledge of key business drivers to maximize FSP staff performance.
- Extensive clinical operations experience across multiple studies and programs, with the agility to adapt to an evolving pipeline.
- Strong cross-functional knowledge of drug development and expertise in clinical trial phases (I–IV) across various disease areas.
- Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels.
- Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, and team building.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
- Strong project management capabilities, including risk assessment, contingency planning, and vendor oversight within an insourced FSP model.
- Collaborative mindset with the ability to partner effectively with internal and external stakeholders.
- Approximately 12 years of clinical research / project management experience preferably with both a sponsor company and/or FSP vendor managing insourced clinical trials.
- Line management experience is advantageous
- Excellent communicator and presenter
- Deep knowledge of project/program management skills
Nice To Haves
- Experience in a Biotech/Pharma environment is preferred
Responsibilities
- Manage up to 20 FSP staff assigned across the portfolio to deliver the CTDU’s program and study-level operational objectives.
- Lead resource forecasting and assignment to meet key business drivers and maximize FSP performance within annual operating plan.
- Develop and revise role-specific SOPs to drive consistency and quality across FSP staff.
- Design and implement training programs in collaboration with FSP vendors and CTDU stakeholders
- Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions and policy compliance.
- Represent CTDU in FSP vendor governance and oversight activities.
- Monitor and report applicable FSP role performance metrics.
- Partner with CTDU stakeholders to align on goals and promote continuous improvement.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
