Senior Manager, Clinical Study Lead, Inflammation & Immunology

About the Role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, accountable for the global execution of large and complex clinical trials from study design through close out. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Lead the cross-functional study team as the primary point of contact for assigned studies, with high independence and 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 clear mitigation plans.
• Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit and inspection ready.
• Manage study close-out activities and contribute to clinical study reports and lessons learned.
• Supervise, coach, and develop Clinical Trial Management staff while driving innovation and process improvement across the department.

Qualifications

• Bachelors degree and 8+ years of relevant clinical trial experience.
• Extensive experience in global clinical trial operations, with 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.

Preferred Qualifications

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

Location and Work Model

Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
Work model/flexibility: Primarily on-site with hybrid flexibility
Travel percentage: Up to 25%

Pay

Salary Range (annually): $150,500.00 - $245,500.00