Associate Director Clinical Data Management Program Lead
Regeneron Pharmaceuticals
Summary
Lead the strategic management of CDM activities across assigned clinical programs, ensuring quality, timelines, and budgets are met while collaborating with senior leadership, clinical study teams, external vendors, and collaboration partners.
Job description
Discover your role:
- 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
Requirements
- Bachelor's degree in Mathematics, Science, or a related field
- 10+ years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry
- 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
- Certified Clinical Data Manager (CCDM) certification is preferred
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.