Associate Director, Data Validation Strategy
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Data Validation Strategy to join our Clinical Data Management organization, leading the strategy and execution of integrated data review, helping ensure our clinical data is high-quality and inspection-ready. You will collaborate with Biostatistics, Clinical Data Reporting, Quantitative Innovation and Statistical Strategy (QISS), and study teams.
Job description
When & where
- Location: Warren, NJ, Armonk or Tarrytown, NY
- Work model: Primarily on-site with hybrid flexibility
- Travel percentage: Up to 25%
Discover your role
- Lead the implementation and execution of the Integrated Data Review (IDR) strategy, operating model, standards, and governance
- Oversee the development, execution, and quality of Data Review Plans (DRPs), including issue tracking, escalation, and resolution
- Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams delivering risk-based data review aligned with critical-to-quality factors
- Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement
- Support the development of SOPs, work instructions, templates, and training materials for IDR activities
- Lead training, coaching, and change management to drive adoption of IDR across clinical and external data domains
- Drive innovation, automation, and AI-enabled analytics initiatives
- Manage, mentor, and develop the Integrated Data Review and Quality team
This role requires
- Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
- 10+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or healthcare industry and 5+ years of people, team, and project leadership experience
- Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes
- Strong working knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles
- Experience supporting inspection readiness activities
- Experience with data review tools, visualization, and analytics for proactive issue detection
Requirements
- Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
- 10+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or healthcare industry
- 5+ years of people, team, and project leadership experience
- Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes
- Strong working knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles
- Experience supporting inspection readiness activities
- Experience with data review tools, visualization, and analytics for proactive issue detection
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- 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.