Associate Director, Country Site & Operations FSP Oversight Manager

Biogen; Baar; Vor Ort; CHF 220.000 - 320.000; Vollzeit

Zusammenfassung

Biogen Baar, Switzerland is seeking an Associate Director, Country & Site Operations FSP Oversight Manager to lead the FSP insourcing model. You will drive delivery excellence across country- and site-level operations, align stakeholders, and shape CSO strategy while embedding robust processes and quality standards.

With ~12 years in clinical research or operations, you will mentor staff, manage resources and vendors, and ensure regulatory compliance (GCP/ICH).

Qualifikationen

• BA or BSc in a scientific discipline; advanced degree preferred.
• ~12 years of clinical research/clinical operations experience.
• Experience managing resources, vendors, and cross-functional stakeholders.
• Proven ability to manage and oversee FSP staff, including planning and performance.
• Strong knowledge of drug development and regulatory guidelines (GCP/ICH).

Aufgaben

• Lead and manage 20–25 FSP staff across country/site portfolio.
• Forecast resources, assign, and prioritize to meet regional needs.
• Develop and implement role-specific processes and quality expectations.
• Design training and onboarding programs with vendors and CSO leaders.
• Oversee onboarding/offboarding of FSP resources and policy compliance.
• Represent CSO in FSP governance, oversight, and performance forums.
• Monitor FSP performance metrics, quality indicators, and risks.
• Collaborate with regional leaders and study teams to align goals.

Kenntnisse

GCP/ICH knowledge

Regulatory compliance

Vendor governance

Cross-functional leadership

Project management

FSP oversight

Ausbildung

BA/BSc in scientific discipline

Advanced degree preferred

Jobbeschreibung

For our offices in Baar we are recruiting for a Associate Director, Country & Site Operations FSP Oversight Manager

About This Role:

As the Associate Director, Country & Site Operations Functional Service Provider (FSP) Oversight Manager, you will play a pivotal role within the Country & Site Operations (CSO) team. You will partner with CSO leadership and cross-functional stakeholders to drive and manage the CSO’s FSP insourcing model. This role is crucial in overseeing and developing FSP staff who support country- and site-facing clinical trial execution, ensuring the embedding of consistent, efficient processes across regions and therapeutic areas. Your work will ensure alignment with CSO’s internal and external stakeholders on FSP role execution, performance, quality, and delivery expectations. Additionally, you will contribute to shaping CSO operational strategy and continuous improvement as part of the CSO extended leadership model. Through varied responsibilities, you will have the opportunity to impact the execution of clinical trials and support the broader strategic goals of the business.

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.
• 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.

Who You Are:

You are an experienced professional in clinical research who thrives in managing complex operational objectives. Your insightful approach allows you to leverage your strong knowledge of country and site operations to maximize FSP staff performance. You possess excellent leadership qualities and organizational skills, with a knack for mentoring and building strong relationships across various organizational levels and geographies. Your collaborative mindset and effective communication skills enable you to partner seamlessly with internal and external stakeholders, driving consistent delivery and continuous improvement. You are adept at navigating regulatory environments and possess a deep understanding of drug development phases and quality expectations.

Required Skills:

• B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
• Approximately 12 years of clinical research, clinical operations, country/site operations, or project management experience.
• Experience managing resources, vendors, and cross-functional stakeholders; line management experience is advantageous.
• Proven ability to manage and oversee FSP staff, including resource planning, training, performance management, and workload prioritization.
• Strong cross-functional knowledge of drug development, including clinical trial phases I-IV.
• Effective line management and mentoring skills.
• Excellent leadership, communication, and organizational skills.
• In‑depth knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.
• Strong project management capabilities.

Preferred Skills:

• Collaborative, site‑centric mindset with the ability to partner effectively with internal and external stakeholders.

Job Level:

Management

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.

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