Senior Manager, Clinical Study Lead, Inflammation & Immunology

Regeneron Pharmaceuticals • Warren, MI

7d • Hybrid

About The Position

Regeneron is seeking a Senior Clinical Study Lead to join its Clinical Trial Management team and lead the global execution of large, complex clinical trials from study design through closeout. The role is accountable for delivering studies on time, within budget, and in accordance with ICH/GCP requirements and Regeneron SOPs. It leads cross-functional study teams, oversees CROs and vendors, supervises Clinical Trial Management staff, and drives process improvement. The position is based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts. It is primarily on-site, with hybrid flexibility, and involves travel up to 25%.

Requirements

• Bachelor’s degree.
• At least 8 years of relevant clinical trial experience.
• Extensive experience in global clinical trial operations and 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, including CTMS, EDC, and IVRS/IWRS, and in MS 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 maintain audit and inspection readiness.
• 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

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability insurance.
• Paid time off.
• Family support benefits.

What This Job Offers

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