Senior Manager, Global Site Start-Up Lead

Overview

Senior Manager, Global Site Start-Up Lead in Global Development, leading strategic site and country start-up activities for complex, high-profile clinical trials across Regeneron's global portfolio.

What you'll do

• 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.

What you'll need

• 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.

Nice to have

• 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.

Details

• Location: United States (Remote) or Regeneron office location.
• Work model: Remote or Hybrid, based on business needs.
• Shift: Standard business hours with flexibility to support global teams across time zones.
• Travel: Up to 25%.
• Ability to participate in meetings across multiple global time zones.
• Ability to work primarily in a computer-based environment.