Senior Manager, Global Site Start Up Lead

BioSpace; United States; Remote; USD 134.000 - 219.000; Vollzeit

Benefits dieser Stelle

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Zusammenfassung

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities for complex global trials. You will partner with Clinical Operations, Regulatory Affairs, CROs, and teams to accelerate study activation while maintaining high-quality, compliant processes.

The role requires 8+ years in pharma/biotech, strong ICH-GCP knowledge, and demonstrated leadership of cross-functional teams and vendors.

Qualifikationen

• Bachelor's degree required; 8+ years in pharma/biotech/clinical research.
• Extensive experience leading global clinical trial start-up activities including country/site activation.
• Strong knowledge of ICH-GCP guidelines and global study start-up processes.
• Proven ability to lead cross-functional teams and manage vendors/CROs.
• Excellent project management, negotiation, and risk management skills.

Aufgaben

• Develop and execute global site and country start-up strategies for complex trials, identifying risks and mitigations.
• Lead site activation planning and forecasting to meet study milestones.
• Collaborate with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to drive start-up execution.
• Monitor start-up metrics and use data trends to inform decisions.
• Oversee site activation activities, including regulatory document collection and milestone tracking.
• Provide leadership to CRO partners and internal teams to ensure compliant delivery.
• Serve as primary escalation point for start-up challenges and drive cross-functional alignment.
• Lead and develop Site Start-Up professionals through coaching and performance management.

Kenntnisse

Project management

Cross-functional leadership

Regulatory affairs

Vendor management

Communication

Risk management

Ausbildung

Bachelor's degree

Jobbeschreibung

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

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.

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.

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.

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.

• 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


• Family support benefits

Salary Range (annually)

$134,400.00 - $219,200.00

For jobs in Canada: this posting is for an existing position.

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.