Senior Clinical Study Lead - Hybrid/On-Site, Global Trials

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Senior Clinical Study Lead to oversee global trials in Inflammation & Immunology. You will lead cross-functional teams, ensure study timelines and budgets, and ensure all activities comply with Regeneron SOPs and ICH/GCP, whether conducted in-house or via CRO partners.

The role requires a Bachelor’s degree and 8+ years of trial experience, with strong leadership, trial-management system proficiency, and ability to drive end-to-end study delivery.

Qualifications

• Bachelor’s degree minimum and at least 8 years of relevant clinical trial experience.
• Experience with line management and strong interpersonal/leadership skills.
• Proactive, deadline-driven, and able to influence diverse stakeholders.
• Advanced proficiency in trial management systems and MS Office applications (PowerPoint, Word, Excel, IVRS/IWRS, EDC).

Responsibilities

• Leads cross-functional study team and serves as primary contact for leadership.
• Oversees CRF, DMP, monitoring plans, data review plans, SAP, etc.
• Manages CTMS setup and TMF maintenance.
• Identifies outsourcing needs and oversees CRO/vendor engagement and management.
• Monitors site activation, recruitment, data entry, and deviations from plan.
• Oversees study close-out activities including database lock and budget reconciliation.

Skills

Leadership

Line management

Stakeholder influence

Time management

Proactive mindset

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

Job description

Regeneron Pharmaceuticals seeks a Senior Clinical Study Lead to oversee global trials in Inflammation & Immunology. You will lead cross-functional teams, ensure study timelines and budgets, and ensure all activities comply with Regeneron SOPs and ICH/GCP, whether conducted in-house or via CRO partners.

The role requires a Bachelor’s degree and 8+ years of trial experience, with strong leadership, trial-management system proficiency, and ability to drive end-to-end study delivery.