Director, Clinical Data Management
About The Position
Regeneron is seeking a Director, Clinical Data Management to serve as Therapeutic Area Head within its Data Management organization. In a hybrid work model, this role sets data management vision and strategy for one or more therapeutic areas, ensures high-quality, inspection-ready clinical data, and coaches and develops managers and data managers. The Director collaborates closely with cross-functional partners, CROs, and outsourcing vendors. The position is based in Cambridge, Massachusetts; Warren, New Jersey; or Armonk, New York. The work model is mostly onsite with hybrid flexibility. The role offers the opportunity to contribute to a fast-growing, science-driven organization developing medicines for people with serious diseases.
Requirements
- Bachelor's degree in Mathematics, Science, or a related field.
- Certified Clinical Data Manager (CCDM) certification.
- 12 or more years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry.
- 5 or more 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 motivating virtual teams in a matrix environment.
- Strong problem-solving, project management, and communication skills.
- Strategic approach and ability to thrive in a fast-paced environment.
Responsibilities
- Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities.
- Oversee portfolio-level execution, track milestones and deliverables, and resolve 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.
- Set data management vision and strategy for one or more therapeutic areas and ensure high-quality, inspection-ready clinical data.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Director
