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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . 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.