Manager, Clinical Study Lead

Location: Onsite work in Armonk, New York, or Warren, New Jersey; up to 25% travel may be required.

Salary: $128,600–$210,000 annually

Company

Regeneron develops and operates biopharmaceutical research programs and clinical studies.

What you will do

• Lead the global execution of smaller or less complex clinical trials, including Phase IV and real-world evidence studies, from design through closeout.
• Coordinate cross-functional study teams and oversee timelines, deliverables, budgets, quality, and corrective actions.
• Provide operational input into protocols, feasibility assessments, country and site selection, investigator meetings, and study-level documentation.
• Manage clinical trial systems such as CTMS and TMF and ensure compliance with clinical trial registry requirements.
• Lead CRO and vendor engagement, contracting, scope management, delivery oversight, and risk mitigation.
• Supervise Clinical Trial Management staff and oversee recruitment, monitoring, database lock, study reporting, and lessons learned.

Requirements

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management, vendor management, study-team collaboration, and cross-functional leadership experience.
• Strong proficiency with Microsoft Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, and trial management systems.
• Experience in global clinical trial operations, including protocol and key study-document development.
• Knowledge of ICH/GCP and relevant regulatory guidelines, with strong project management and organizational skills.

Nice to have

• Experience with Phase IV or real-world evidence studies.

Culture & Benefits

• Inclusive workplace with equal-opportunity employment practices.
• Comprehensive rewards may include annual bonuses, equity awards, retirement or pension benefits, and 401(k) matching.
• Benefits may include medical, dental, vision, life, disability, health and wellness programs, paid time off, and family support.
• Reasonable accommodation is available during recruitment where required.