Senior Manager, Global Site Start-Up Lead

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About the role

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Global Site Start-Up Lead to join our Global Development team , supporting complex, high-profile clinical trials across our global portfolio. In this role, you will lead the strategic execution of site and country start-up activities, driving efficient study activation and operational excellence while ensuring compliance with regulatory requirements and industry standards. Working closely with cross-functional partners, clinical operations teams, and CROs, you will play a critical role in accelerating study timelines, mitigating risks, and enabling the successful delivery of clinical development programs that bring innovative therapies to patients worldwide. When & Where • Location: United States (Remote) or Regeneron office location • Work Model/Flexibility: Remote or Hybrid, based on business needs • Shift Requirements: Standard business hours with flexibility to support global teams across time zones • Travel Percentage: Up to 25% Discover Your Role • Develop and execute global site and country start-up strategies for complex clinical trials, identifying risks, dependencies, and mitigation plans. • Lead site activation planning and forecasting activities to ensure study milestones and timelines are achieved. • Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive efficient study start-up execution. • Monitor and evaluate start-up metrics, leveraging data and trends to improve performance and inform strategic decision-making. • Oversee site activation activities including regulatory document collection, submissions, site initiation readiness, and milestone tracking. • Provide leadership and direction to CRO partners and internal teams to ensure high-quality and compliant start-up delivery. • Serve as the primary escalation point for site start-up challenges, proactively resolving issues and driving cross-functional alignment. • Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives. This Role Requires Must-Haves • Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research industry experience . • Extensive experience leading global clinical trial start-up activities, including country and site activation strategies. • Strong knowledge of ICH-GCP guidelines , clinical trial regulations, and global study start-up processes. • Demonstrated ability to lead cross-functional teams and influence stakeholders across a global organization. • Proven experience managing vendors and CROs, including performance oversight and issue resolution. • Excellent project management, communication, negotiation, and risk management skills. Preferred Qualifications • Previous direct line management experience with responsibility for staff development and performance management. • Experience supporting complex, high-profile, and global clinical development programs. • Strong analytical mindset with a data-driven approach to forecasting, metrics review, and operational decision-making. • Experience driving process improvements and operational excellence initiatives within Clinical Development. • Advanced understanding of country-specific regulatory and site activation requirements across multiple regions. Physical Requirements • Ability to work primarily in a computer-based environment. • Ability to travel domestically and internationally up to 25% as required. • Ability to participate in meetings across multiple global time zones.   Does this sound like you? Apply now to take your first step towards l

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