Senior Manager, Clinical Study Lead, Inflammation & Immunology

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. In this role, you will lead cross-functional study teams and oversee CROs and vendors, ensuring studies are delivered on time, on budget, and in accordance with ICH/GCP and Regeneron SOPs.

You will also supervise Clinical Trial Management staff and drive process improvement initiatives. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

• 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 escape 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

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

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective…