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.

Executive Director, Global Site Management

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.

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
• Demonstrated success leading leaders and managing performance across global, matrixed, and partner-based organizations
• Executive presence and exceptional communication, influence, negotiation, and decision-making skills; able to translate complex issues into clear enterprise choices and mobilize stakeholders to action
• Excellent interpersonal skills and demonstrated collaborative as well as independent working style
• Proactive and self-motivated, ability to align activities with the clinical development plans (CDPs)
• Strong organizational skills with effective use of time and prioritization

Salary

Salary Range (annually) $255,000.00 - $424,900.00

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit

Equal Opportunity

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

About Regeneron

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.