Associate Director, Data Validation Strategy
About The Position
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 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
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
Responsibilities
- 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
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
