Remote Associate Director, Country & Site Ops FSP Oversight

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

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