Associate Director, Clinical Data Management
Regeneron Pharmaceuticals • Warren, MA18d • Hybrid
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Associate Director Clinical Data Management Program Lead
Regeneron Pharmaceuticals•Warren, MA
•Hybrid
About The Position
Regeneron is seeking an Associate Director, Clinical Data Management, Program Lead to lead the strategic management of clinical data management (CDM) activities across assigned clinical programs. The role is accountable for ensuring quality, timelines, and budgets while collaborating with senior leadership, clinical study teams, external vendors, and collaboration partners. It offers the opportunity to contribute to a fast-growing, science-driven organization developing medicines for people with serious diseases. The position is based in Warren, New Jersey; Armonk, New York; or Tarrytown, New York. The work model is mostly onsite, with hybrid flexibility. The role leads CDM program deliverables, provides expertise throughout protocol design and study execution, manages program resources and risks, and supports regulatory inspection readiness. It also includes mentoring team members and, where applicable, managing staff through recruitment, development, and performance management.
Requirements
- Bachelor's degree in Mathematics, Science, or a related field.
- 10 or more years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
- 5 or more years of people management experience.
- Solid understanding of 21 CFR Part 11, ICH-GCP guidelines, and CDISC standards for data collection.
- Proven record of leading studies and study teams, with the ability to motivate virtual teams in a matrix environment.
- Strong problem-solving, project management, and communication skills in a fast-paced setting.
Nice To Haves
- Certified Clinical Data Manager (CCDM) certification.
Responsibilities
- Lead the overall success of CDM deliverables across studies and programs.
- Communicate program status, risks, and issues proactively to collaborators and develop mitigation strategies.
- Provide CDM expertise during protocol design, study start-up, and study conduct, promoting consistent standards and best practices.
- Oversee program timelines, resources, and budgets, and serve as the escalation point for program and study issues.
- Track metrics and KPIs, and manage Quality Events, CAPAs, and process deviations.
- Represent CDM in review committees, CRO governance, and joint meetings with collaborators.
- Drive inspection readiness and coordinate CDM activities during regulatory inspections.
- Mentor and coach team members, and, where applicable, manage staff through recruitment, development, and performance management.
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, medical, dental, vision, life and disability insurance benefits, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
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