Associate Director, Country & Site Operations

Biogen

. Manage up to 20-25 FSP staff assigned across the clinical portfolio.

Posted 9/28/2026full-timeRemote • United StatesSenior💰 $171,000 - $235,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical operations and project management, with a strong focus on resource planning, vendor oversight, and compliance with GCP and ICH guidelines. Proven ability to lead cross-functional teams and drive continuous improvement in clinical trial execution and operational efficiency.

Highest-signal resume keywords

Clinical Research ManagementResource PlanningVendor OversightGCP and ICH Guidelines KnowledgeProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExecutionPerformance ManagementRisk AssessmentContingency PlanningWorkload PrioritizationBudget ForecastingQuality ExpectationsTraining Program DevelopmentData AnalysisSite Engagement

Soft Skills

Effective Line ManagementMentoring SkillsCollaborative MindsetStakeholder PartnershipContinuous Improvement

Industry Keywords

FSP ManagementClinical OperationsDrug DevelopmentClinical Trial Phases I–IVCountry ActivationSite-Centric ExecutionRegulatory RequirementsQuality IndicatorsPerformance MetricsCross-Functional Collaboration

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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