Associate Director, Country & Site Operations

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $171k - $235.5k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Manage up to 20-25 FSP staff assigned across the clinical portfolio. • 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. • Develop, refine, and implement role-specific processes, guidance, and quality expectations. • Design and implement training and onboarding programs with FSP vendors, CSO leaders, and cross-functional stakeholders. • Oversee onboarding and offboarding of FSP resources. • Represent CSO in FSP vendor governance, oversight, and performance management forums. • Monitor, analyze, and report FSP role performance metrics, quality indicators, workload trends, and delivery risks. • Partner with regional leaders, study teams, Medical, Quality, and other stakeholders to align goals and strengthen site-centric execution. • Drive continuous improvement of the FSP operating model to improve scalability, efficiency, role clarity, quality, and cost effectiveness.

🎯 Requirements

• Bachelors degree in a scientific discipline; advanced degree preferred. • 8+ years of clinical research, clinical operations, country/site operations, or project management experience. • Experience managing resources, vendors, and cross-functional stakeholders is required. • Proven ability to manage and oversee FSP staff, including resource planning, training, performance management, and workload prioritization. • Strong knowledge of country and site operations, clinical trial execution, and key business drivers. • 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. • 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.

🏖️ 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 • 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 • Short term and long-term incentives, including cash bonus and equity incentive opportunities