Associate Director, Data Validation Strategy

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

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

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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.