Global Site Start-Up Lead — Remote/Hybrid

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 join our Global Development team.

You will drive strategic execution of site and country start-up activities, ensuring compliance and timely study activation across a global portfolio. You will collaborate with Clinical Operations, Regulatory Affairs, CROs, and other partners to optimize start-up timelines, manage vendor relationships, and deliver high-quality, compliant start-up delivery worldwide.

Qualifications

• Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research experience.
• Extensive experience leading global start-up activities for country and site activation.
• Strong knowledge of ICH-GCP guidelines and global study start-up processes.

Responsibilities

• Develop and execute global site and country start-up strategies for complex trials.
• Lead site activation planning and forecasting to meet milestones.
• Collaborate with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to ensure efficient start-up execution.
• Monitor start-up metrics and leverage data to improve performance and planning.
• Oversee regulatory document collection, submissions, and site initiation readiness.
• Provide leadership to CRO partners and internal teams for compliant delivery.
• Escalate and resolve start-up challenges with cross-functional alignment.
• Coach and develop Site Start-Up team members.

Skills

Cross-functional leadership

Project management

Vendor management

Regulatory collaboration

Risk management

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals Inc. is seeking a Senior Manager, Global Site Start-Up Lead to join our Global Development team.

You will drive strategic execution of site and country start-up activities, ensuring compliance and timely study activation across a global portfolio. You will collaborate with Clinical Operations, Regulatory Affairs, CROs, and other partners to optimize start-up timelines, manage vendor relationships, and deliver high-quality, compliant start-up delivery worldwide.