Lead, Data Validation & IDR Strategy

Regeneron Pharmaceuticals; Warren (MI); Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director, Data Validation Strategy to lead the Integrated Data Review strategy within Clinical Data Management. You will shape the IDR operating model, governance, and DRP quality while collaborating with Biostatistics, QISS, and study teams to ensure inspection-ready data.

You will drive KPIs, support SOP development, and mentor the IDR and Quality teams. The role emphasizes training, change management, and AI-enabled analytics in a primarily on-site

Qualifications

• 10+ years of Clinical Data Management experience in biotech/pharma/healthcare
• 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

Skills

Leadership

Clinical Data Management

Data review

Quality management

Risk-based data management

Project management

Inspection readiness

Education

Bachelor’s degree in Life Sciences, Statistics, Computer Science, or related field

Job description

Regeneron Pharmaceuticals seeks an Associate Director, Data Validation Strategy to lead the Integrated Data Review strategy within Clinical Data Management. You will shape the IDR operating model, governance, and DRP quality while collaborating with Biostatistics, QISS, and study teams to ensure inspection-ready data.

You will drive KPIs, support SOP development, and mentor the IDR and Quality teams. The role emphasizes training, change management, and AI-enabled analytics in a primarily on-site