Global Site Start-Up Lead - Remote

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

Job summary

Regeneron Pharmaceuticals is seeking a Senior Manager, Global Site Start-Up Lead to join the Global Development team. You will lead strategic execution of site and country start-up activities, accelerating study activation while ensuring regulatory compliance and quality.

You will collaborate with Clinical Operations, Regulatory Affairs, CROs, and cross-functional partners to drive efficient start-up delivery and manage a team of Site Start-Up professionals across global programs.

Qualifications

• Bachelor’s degree and 8+ years in pharma/clinical research industry.
• Experience leading global site start-up activities, including country and site activation strategies.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, and start-up processes.

Responsibilities

• 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 to meet milestones and timelines.
• Partner with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to drive start-up execution.
• Monitor start-up metrics and use data 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 start-up delivery.
• Serve as escalation point for site start-up challenges and cross-functional alignment.
• Manage and develop a team of Site Start-Up professionals through coaching and career development.

Skills

Leadership

Cross-functional

Project management

Communication

Negotiation

Risk management

Education

Bachelor’s degree

Job description

Regeneron Pharmaceuticals is seeking a Senior Manager, Global Site Start-Up Lead to join the Global Development team. You will lead strategic execution of site and country start-up activities, accelerating study activation while ensuring regulatory compliance and quality.

You will collaborate with Clinical Operations, Regulatory Affairs, CROs, and cross-functional partners to drive efficient start-up delivery and manage a team of Site Start-Up professionals across global programs.