Senior Clinical Study Lead - Inflammation & Immunology

Regeneron Pharmaceuticals, Inc.; Warren (MI); Hybrid; USD 151,000 - 246,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Clinical Study Lead to manage global, large-scale clinical trials from design to close-out.

You will lead cross-functional study teams, oversee CROs, monitor budgets, timelines, and quality, and advance processes within the Clinical Trial Management group. Ideal candidates have a Bachelor’s degree and 8+ years of global clinical operations, strong leadership, budget and vendor management, and expertise with CTMS/EDC.

Qualifications

• Bachelor’s degree with 8+ years of clinical trial experience.
• Extensive experience in global clinical trial operations.
• Line management experience and ability to build strong study teams.
• Strong budget, vendor management, and negotiation skills.
• Exceptional interpersonal, communication, and influencing skills.

Responsibilities

• Lead cross-functional study teams as the primary contact for assigned studies.
• Provide operational input into protocol development and key documents.
• Lead feasibility assessments, site evaluation, investigator meetings, and patient recruitment strategies.
• Select and oversee CROs and third-party vendors for delivery against scope of work.
• Manage study budgets and timelines with risk mitigation and escalation as needed.
• Oversee data quality, protocol deviations, and study systems to ensure audit readiness.
• Supervise Clinical Trial Management staff and drive process improvement.

Skills

Clinical trials

Global operations

Budget management

Vendor management

Leadership

Education

Bachelor’s degree

Tools

CTMS

EDC

IVRS/IWRS

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Clinical Study Lead to manage global, large-scale clinical trials from design to close-out.

You will lead cross-functional study teams, oversee CROs, monitor budgets, timelines, and quality, and advance processes within the Clinical Trial Management group. Ideal candidates have a Bachelor’s degree and 8+ years of global clinical operations, strong leadership, budget and vendor management, and expertise with CTMS/EDC.