Senior Manager, Global Site Start-Up Lead
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
Requirements
- Bachelor's degree
- 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.