Senior Manager, Global Site Start-Up Lead

Regeneron Pharmaceuticals, Inc.; United States; Hybride; USD 134 000 - 219 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities for complex clinical trials across the global portfolio.

You will partner with Clinical Operations, Regulatory Affairs, CROs, and cross-functional teams to accelerate study activation while ensuring regulatory compliance. This role requires strong leadership, vendor management experience, and a data-driven approach to forecasting and risk

Qualifications

• Bachelor's degree and 8+ years of pharmaceutical/clinical research experience.
• Experience leading global site start-up activities.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Ability to influence stakeholders and lead cross-functional teams.
• Vendor/CRO management experience.
• Excellent project management, communication, and risk management skills.

Responsabilités

• 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.

Connaissances

Clinical operations

Vendor management

Cross-functional leadership

Regulatory knowledge

Project management

ICH-GCP knowledge

Formation

Bachelor's degree

Description du poste

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? We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

Salary Range (annually)
$134,400.00 - $219,200.00