Senior Manager, Clinical Study Lead, Inflammation & Immunology

Regeneron Pharmaceuticals

8d • $150,500 - $245,500 • Hybrid

About The Position

Regeneron is seeking a Senior Clinical Study Lead to join its Clinical Trial Management team. The role is accountable for global execution of large and complex clinical trials from study design through closeout. The successful candidate will lead cross-functional study teams and oversee CROs and vendors to ensure studies are delivered on time, within budget, and in accordance with ICH/GCP and Regeneron SOPs. The position also supervises Clinical Trial Management staff and drives process improvement initiatives. It offers an opportunity to contribute to a science-driven organization developing medicines for serious diseases.

The position is based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts. It is primarily on-site, with hybrid flexibility, and requires up to 25% travel.

Requirements

• Bachelor’s degree.
• At least 8 years of relevant clinical trial experience.
• Extensive experience in global clinical trial operations.
• Knowledge of ICH/GCP and regulatory guidelines.
• Line management experience and the ability to build, lead, and develop productive study teams.
• Strong budget management, vendor management, and negotiation skills.
• Exceptional interpersonal, communication, and influencing skills across a wide range of stakeholders.

Nice To Haves

• Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and Microsoft applications.
• Awareness of relevant industry trends and experience driving process improvement.

Responsibilities

• Lead cross-functional study teams as the primary point of contact for assigned studies, with accountability for timelines, budget, and quality.
• Provide operational input into protocol development and key study documents, including data management, monitoring, and statistical analysis plans.
• Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies.
• Select, contract, and oversee CROs and third-party vendors to ensure delivery against the scope of work.
• Manage study budgets and timelines, identify risks, and escalate issues with mitigation plans.
• Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit- and inspection-ready.
• Manage study closeout activities and contribute to clinical study reports and lessons learned.
• Supervise, coach, and develop Clinical Trial Management staff.
• Drive innovation and process improvement across the department.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior