Executive Director, Global Site Management

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Global Site Management team.

The Executive Director, Global Site Management provides enterprise-level strategic leadership and organizational accountability for global site-facing capabilities. The role sets the global vision and operating strategy for site management, monitoring execution, resource and budget planning, and CRO/FSP/vendor performance across the clinical development portfolio. They will own the continued evolution of the global site management operating model, ensuring regional capabilities, roles, governance, and deployment strategies deliver consistent quality, speed, scalability, and value. The role serves as the senior functional authority for enterprise initiatives requiring regional or global site-management expertise and partners with Therapeutic Area/Program Clinical Trial Management (CTM), Clinical Science, Quality, and Development Operations leadership to optimize portfolio performance.

This role advises senior and executive management, represents the function in key governance forums, and engages external vendors and collaboration partners at the most senior levels. They are accountable for translating development strategy into a differentiated global site-management capability that advances the Regeneron clinical trial portfolio and delivers industry-leading performance.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Tarrytown, NY, Warren, NJ or Armonk, NY
• 4 days per week on site
• Up to 40% Travel may be required

Discover your role:

• Provide enterprise accountability for the strategy, organizational leadership, performance, and continuous evolution of Global Site Management, including the following outcomes:
• Establish and advance the global strategy for country key opinion leader, investigator, and site relationships
• Set direction and governance for global study execution, clinical site monitoring, and issue escalation across the portfolio
• Sponsor risk-based, study-specific monitoring strategies and ensure their consistent implementation and effectiveness
• Define enterprise performance, quality, compliance, and productivity expectations for site management and monitoring activities
• Champion standardization, digital enablement, innovation, and measurable value creation across the global operating model
• Own the global workforce and capability strategy for site management, including multi-year FTE and external-capacity forecasts, headcount planning, allocation, utilization, leadership development, and succession across CTL and CRA organizations
• Hold executive accountability for the global vendor strategy, CRO/FSP contracting worth $10M for CRAs and $10M for CTLs, associated investment, capacity, and performance. Lead senior-level vendor governance, commercial and operational decisions, and corrective interventions when performance or quality is at risk
• Oversee management of data and quality issues at the country/site level, partnering with study management, data management, Quality Management Leads and other stakeholders
• Partners with Global Monitoring Oversight, Central Monitoring, Vendor Relationship Management and counterparts at CROs to ensure alignment on (risk-based) monitoring strategies, standards and training requirements
• Serve as the enterprise thought leader and senior subject matter authority for global site management. Influence internal strategy and external industry practice, sponsor cross-portfolio transformation, and build executive alignment for new capabilities, operating-model changes, and strategic investments
• Establish the global CTL capability model, accountabilities, standards, and measures that support study feasibility, site identification and selection, patient recruitment and retention, and resolution of complex investigator-site issues

This role requires:

• Minimum Bachelors Degree (Advanced Degree preferred) with 17+ years of experience including 10+ years of functional leadership and people management
• Expert knowledge of drug development, global clinical operations, clinical monitoring, site management, GCP, and applicable regulations, with demonstrated ability to translate scientific and development strategy into scalable operational capabilities
• Extensive experience leading global clinical trial operations and enterprise transformation across multiple therapeutic areas, regions, and development stages
• Experience working with/establishing global clinical site relationships; Cross cultural awareness and fluent in Business English
• Proven executive leadership in setting vision, leading through ambiguity, building high-performing global organizations, developing senior talent, shaping culture, and delivering sustained change at scale

…