Associate Director Clinical Data Management Program Lead
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 delivering CDM work with appropriate quality and within timelines and budgets, in collaboration with senior leadership, clinical study teams, external vendors, and collaboration partners. It offers the opportunity to contribute to a 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 deliverables across studies and programs, provides CDM expertise throughout protocol design and study execution, oversees program resources and budgets, and serves as an escalation point. It also supports inspection readiness, quality oversight, committee and governance participation, and team mentoring and management.
Requirements
- Bachelor's degree in Mathematics, Science, or a related field.
- At least 10 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
- At least 5 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, insurance benefits, paid time off, and family support benefits.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
