Associate Director, Clinical Trial Delivery Unit FSP Oversight Manager

Biogen, Inc.

Job Overview

Location

Remote, USA

Job Type

Full-time

Full Job Description

📋 Description

• The Associate Director, Clinical Trial Delivery Unit (CTDU) Functional Service Provider (FSP) Oversight Manager partners with CTDU Leadership to drive and manage Biogen’s robust FSP insourcing model, overseeing up to 20 FSP staff to ensure consistent, efficient processes and alignment with internal and external stakeholders on FSP role execution and performance.
• Day-to-day responsibilities include managing FSP staff assignments across the portfolio, leading resource forecasting and assignment to meet business drivers, developing and revising role-specific SOPs, designing and implementing training programs with FSP vendors and CTDU stakeholders, overseeing onboarding and offboarding of FSP resources, representing CTDU in FSP vendor governance, monitoring and reporting FSP performance metrics, and partnering with stakeholders to align on goals and promote continuous improvement.
• Biogen is a global mid-sized biotechnology company committed to delivering life-changing medicines, fostering an environment where individual contributions make a significant impact, and building a culture of inclusion and belonging that empowers employees to grow and innovate.
• In this role, the individual will develop deep expertise in clinical trial operations and FSP oversight, strengthen leadership and cross-functional collaboration skills, influence CTDU’s strategic direction as part of the Extended Leadership Team, and gain experience managing complex vendor relationships and insourced operational models in a high-impact, mission-driven organization.

🎯 Requirements

• Approximately 12 years of clinical research / project management experience preferably with both a sponsor company and/or FSP vendor managing insourced clinical trials
• 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
• 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
• Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels

🏖️ 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

Skills & Technologies

GCP

Junior

Remote

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Biogen, Inc.

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About Biogen, Inc.

Biogen is an American biotechnology company that develops and manufactures therapies for neurological and neurodegenerative diseases. Founded in 1978, the company focuses on treatments for conditions such as multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, and amyotrophic lateral sclerosis (ALS). It also produces biosimilar drugs for immune and inflammatory diseases. Biogen operates globally with research, development, and manufacturing facilities supporting its mission to improve outcomes for patients with serious neurological disorders.

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