Global Site Start-Up Lead — Strategy & Activation

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

Job summary

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities across a global portfolio. You will lead activation planning, risk mitigation, and cross-functional collaboration with Clinical Operations, Regulatory Affairs, and CROs to accelerate study timelines and ensure compliance.

This role supports remote or hybrid work arrangements in the United States, with travel up to 25%.

Qualifications

• Bachelor's degree and 8+ years in pharma/clinical research.
• Extensive experience leading global start-up activities.
• Strong knowledge of ICH-GCP guidelines and global start-up processes.
• Experience managing CROs and vendors.

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 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.

Skills

ICH-GCP knowledge

Vendor management

Project management

Cross-functional leadership

Communication & negotiation

Regulatory collaboration

Education

Bachelor's degree

Job description

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities across a global portfolio. You will lead activation planning, risk mitigation, and cross-functional collaboration with Clinical Operations, Regulatory Affairs, and CROs to accelerate study timelines and ensure compliance.

This role supports remote or hybrid work arrangements in the United States, with travel up to 25%.