Senior Manager, Global Site Start-Up Leader

Regeneron Pharmaceuticals, Inc (USA); United States; Hybride; USD 134 000 - 219 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Global Site Start-Up Lead to drive global site and country activation for complex clinical trials. You will lead activation planning, partner with clinical operations, regulatory affairs, CROs, and other stakeholders to accelerate start-up delivery.

This role requires 8+ years in pharma/biotech with strong ICH-GCP knowledge and proven ability to lead cross-functional teams across regions and vendors, ensuring compliant, timely

Qualifications

• Bachelor's degree required with 8+ years in pharma/biotech/clinical research.
• Extensive experience leading global site and country start-up activities.
• Strong knowledge of ICH-GCP guidelines and global study start-up processes.
• Ability to lead cross-functional teams and influence stakeholders globally.
• Experience managing vendors and CROs with performance oversight.

Responsabilités

• Develop and execute global site and country start-up strategies for complex trials.
• Lead site activation planning and forecasting to meet milestones.
• Partner with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to drive start-up execution.
• Monitor start-up metrics and leverage data to inform decisions.
• Oversee regulatory document collection, submissions, and site readiness milestones.
• Provide leadership to CRO partners and internal teams; escalate and resolve start-up challenges.
• Manage and develop Site Start-Up teams through coaching and career development.

Connaissances

Global start-up leadership

ICH-GCP knowledge

Cross-functional collaboration

Vendor/CRO oversight

Project management

Risk management

Stakeholder influence

Formation

Bachelor's degree

Description du poste

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Global Site Start-Up Lead to drive global site and country activation for complex clinical trials. You will lead activation planning, partner with clinical operations, regulatory affairs, CROs, and other stakeholders to accelerate start-up delivery.

This role requires 8+ years in pharma/biotech with strong ICH-GCP knowledge and proven ability to lead cross-functional teams across regions and vendors, ensuring compliant, timely