Associate Director, Clinical Trial Delivery Unit FSP Oversight Manager
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AI Summary
About This Role
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.
What You’ll Do
- 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.
Who You Are
- 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.
Required Skills
- 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
Preferred Skills
Experience in a Biotech/Pharma environment is preferred
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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