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Director, Clinical Data Management

L7

regeneronSomerville, MA3 days ago
Director, Clinical Data Management At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, Clinical Data Management to join our Data Management organization, serving as Therapeutic Area Head in a hybrid work model. In this role, you will set the data management vision and strategy for one or more therapeutic areas, ensure high-quality, inspection-ready clinical data, and coach and develop a team of managers and data managers. You will collaborate closely with cross-functional partners, CROs, and outsourcing vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Location: Cambridge, MA; Warren, NJ; Armonk, NY
Work model: mostly onsite with hybrid flexibility Discover your role:
  • Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities
  • Oversee portfolio-level execution, tracking milestones and deliverables, and resolving risks and critical issues
  • Partner with senior leadership to shape department goals, organizational structure, and resource allocation
  • Hold CROs and vendors accountable for quality and compliance, and help build long-term outsourcing partnerships
  • Drive inspection and audit readiness, overseeing the team through inspections and quality gap resolution
  • Build strong relationships across teams by negotiating effectively, managing conflict, and collaborating
  • Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums This role requires:
  • Bachelor's degree in Mathematics, Science, or a related field, plus a Certified Clinical Data Manager (CCDM) certification
  • 12+ years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry
  • 5+ years of people management experience
  • Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
  • Proven record of leading studies and study teams, and of motivating virtual teams in a matrix environment
  • Strong problem-solving, project management, and communication skills, with a strategic approach and the ability to thrive in a fast-paced environment
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.
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Level

ManagerL7

Location

Somerville, MA

Occupation

Medical and Health Services Managers

Industry

Research and Development in Biotechnology

Posted

3 days ago

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