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Executive Director, Global Site Management

Regeneron Pharmaceuticals, Inc.

Executive Director, Global Site ManagementAt 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, NY4 days per week on siteUp to 40% Travel may be requiredDiscover 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 relationshipsSet direction and governance for global study execution, clinical site monitoring, and issue escalation across the portfolioSponsor risk-based, study-specific monitoring strategies and ensure their consistent implementation and effectivenessDefine enterprise performance, quality, compliance, and productivity expectations for site management and monitoring activitiesChampion standardization, digital enablement, innovation, and measurable value creation across the global operating modelOwn 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 organizationsHold 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 riskOversee management of data and quality issues at the country/site level, partnering with study management, data management, Quality Management Leads and other stakeholdersPartners with Global Monitoring Oversight, Central Monitoring, Vendor Relationship Management and counterparts at CROs to ensure alignment on (risk-based) monitoring strategies, standards and training requirementsServe 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 investmentsEstablish 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 issuesThis role requires:Minimum Bachelors Degree (Advanced Degree preferred) with 17+ years of experience including 10+ years of functional leadership and people managementExpert 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 capabilitiesExtensive experience leading global clinical trial operations and enterprise transformation across multiple therapeutic areas, regions, and development stagesExperience working with/establishing global clinical site relationships; Cross cultural awareness and fluent in Business EnglishProven executive leadership in setting vision, leading through ambiguity, building high-performing global organizations, developing senior talent, shaping culture, and delivering sustained change at scaleDemonstrated success leading leaders and managing performance across global, matrixed, and partner-based organizationsExecutive presence and exceptional communication, influence, negotiation, and decision-making skills; able to translate complex issues into clear enterprise choices and mobilize stakeholders to actionExcellent interpersonal skills and demonstrated collaborative as well as independent working styleProactive and self-motivated, ability to align activities with the clinical development plans (CDPs)Strong organizational skills with effective use of time and prioritization

Vacancy posted 3 days ago
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