Associate Director, Country & Site Operations FSP Oversight Manager

Biogen, Inc.; Northern (KY); Hybrid; USD 171,000 - 236,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life insurance

Fitness & Wellness programs

Paid vacation + holidays

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Tuition reimbursement of up to $10,000

Job summary

Biogen, Inc. is seeking an Associate Director to lead Country & Site Operations FSP oversight, coordinating cross-functional teams to drive insourcing models across regions. You will supervise 20–25 FSP staff, shaping processes, training, and performance to ensure high-quality trial execution.

This role partners with CSO leadership and vendors to optimize resources, cost, and delivery. The ideal candidate brings 8+ years in clinical operations, strong leadership, and deep knowledge of GCP/ICH

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 8+ years in clinical research/clinical operations/country-site operations or project management.
• Experience managing resources, vendors, and cross-functional stakeholders; line management is advantageous.
• Proven ability to oversee FSP staff, including planning, training, and performance management.
• Strong knowledge of country/site operations, clinical trial execution, and drug development phases I–IV.
• Excellent leadership, communication, and organizational skills; adept at problem solving and stakeholder management.
• Deep knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.
• Strong project management skills including risk assessment and vendor oversight.

Responsibilities

• Manage 20–25 FSP staff across clinical portfolio to support country and site objectives.
• Lead resource forecasting, assignment, and prioritization for regional delivery.
• Support FSP budget forecasting and oversight with CSO leadership.
• Develop and implement role-specific processes, guidance, and quality expectations.
• Design training/onboarding programs with FSP vendors and CSO stakeholders.
• Oversee onboarding/offboarding ensuring continuity and policy compliance.
• Represent CSO in vendor governance, oversight, and performance forums.
• Monitor and report FSP performance metrics, quality indicators, and risks.
• Collaborate with regional leaders, study teams, Medical, Quality for alignment and improvement.

Skills

Resource management

Vendor management

Cross-functional collaboration

Leadership

Project management

GCP/ICH knowledge

Clinical operations

Country/site operations

Stakeholder management

Budget forecasting

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

## Associate Director, Country & Site Operations FSP Oversight ManagerApply: Off Campus: Remote, USA: Full time: Posted Today: REQ24231**About This Role**The Associate Director, Country & Site Operations Functional Service Provider (FSP) Oversight Manager partners with CSO leadership and cross-functional stakeholders to drive and manage CSO’s FSP insourcing model. This role oversees and develops FSP staff supporting country- and site-facing clinical trial execution, embedding consistent, efficient processes across regions and therapeutic areas. It ensures alignment with CSO’s internal and externalstakeholders on FSP role execution, performance, quality, and delivery expectations. This role also contributes to shaping CSO operational strategy and continuous improvement as part of the CSO extended leadership model.**What You’ll Do*** Manage up to 20-25 FSP staff assigned across the clinical portfolio to support CSO’s country and site-level operational objectives.* Lead resource forecasting, assignment, and prioritization to support regional delivery needs, portfolio demand, and annual operating plan commitments.* Support FSP budget forecasting and financial oversight, partnering with CSO leadership to optimize resource utilization and external spend.* Develop, refine, and implement role-specific processes, guidance, and quality expectations to drive consistency across FSP staff supporting CSO activities.* Design and implement training and onboarding programs in collaboration with FSP vendors, CSO leaders, and key cross-functional stakeholders.* Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions, role clarity, policy compliance, and continuity of country and site support.* Represent CSO in FSP vendor governance, oversight, and performance management forums.* Monitor, analyze, and report applicable FSP role performance metrics, quality indicators, workload trends, and delivery risks.* Partner with CSO regional leaders, study teams, Medical, Quality, and other stakeholders to align on goals, strengthen site-centric execution, and promote continuous improvement.* Drive continuous improvement and evolution of the FSP operating model, identifying opportunities to improve scalability, efficiency, role clarity, quality, and cost effectiveness**Who You Are**You are an experienced clinical operations leader with expertise in country/site operations, resource management, and cross-functional collaboration, with a strong track record of driving clinical trial execution and operational excellence. You thrive in matrixed environments, excel at leading teams and vendor partnerships, and are passionate about building scalable processes that improve quality, efficiency, and delivery.**Required Skills*** Bachelors degree in a scientific discipline; advanced degree preferred.* 8+ years of clinical research, clinical operations, country/site operations, or project management experience, preferably with both a sponsor company and/or FSP vendor supporting insourced clinical trial delivery.* Experience managing resources, vendors, and cross-functional stakeholders is required; line management experience is advantageous.* Proven ability to manage and oversee FSP staff, including resource planning, training, performance management, and workload prioritization.* Ability to leverage strong knowledge of country and site operations, clinical trial execution, and key business drivers to maximize FSP staff performance.* Strong cross-functional knowledge of drug development and expertise in clinical trial phases I–IV, including country activation, site engagement, study conduct, and inspection readiness.* Effective line management and mentoring skills, with the ability to build strong relationships across all organizational levels and geographies.* Excellent leadership, communication, and organizational skills, with strengths in problem solving, conflict resolution, stakeholder management, and team building. In-depth knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.* Strong project management capabilities, including risk assessment, contingency planning, vendor oversight, and issue escalation within an insourced FSP model.* Collaborative, site-centric mindset with the ability to partner effectively with internal and external stakeholders to drive consistent delivery and continuous improvement.Job Level: Management**Additional Information**The base compensation range for this role is: $171,000.00-$235,500.00Base 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 Biogen. 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.