Global Site Start-Up Lead — Remote-Friendly

Regeneron Pharmaceuticals, Inc.; United States; Hybrid; USD 134,000 - 219,000; Full time

Job summary

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.

You will partner with Clinical Operations, Regulatory Affairs, and CROs to accelerate study activation while ensuring regulatory compliance and operational excellence. Leading a team of Site Start-Up professionals, you will monitor metrics, manage risks, and ensure timely delivery of high-quality start-up

Qualifications

• 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 and global study start-up processes.
• Proven ability to lead cross-functional teams and influence stakeholders across a global organization.
• Experience managing vendors and CROs with performance oversight and issue resolution.
• Excellent project management, communication, negotiation, and risk management skills.

Responsibilities

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

Skills

Global site start-up leadership

Cross-functional collaboration

Regulatory knowledge (ICH-GCP)

Vendor and CRO management

Project management & risk management

Education

Bachelor’s degree

Job description

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.

You will partner with Clinical Operations, Regulatory Affairs, and CROs to accelerate study activation while ensuring regulatory compliance and operational excellence. Leading a team of Site Start-Up professionals, you will monitor metrics, manage risks, and ensure timely delivery of high-quality start-up