Head of Integrated Data Review & Quality

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Presencial; USD 157.000 - 257.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks an Associate Director, Data Validation Strategy to lead the Integrated Data Review (IDR) strategy within Clinical Data Management.

You will shape the operating model, governance, and standards, ensuring high-quality, inspection-ready clinical data and collaboration across Biostatistics, Clinical Data Reporting, QISS, and study teams. The role emphasizes developing DRPs, KPI monitoring, and mentoring the Data Review and Quality team, while advancing

Formación

• Bachelor's degree in Life Sciences, Statistics, Computer Science or related field.
• 10+ years of Clinical Data Management experience in biotech/pharma/healthcare.
• 5+ years of people, team, and project leadership experience.

Responsabilidades

• 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.

Conocimientos

Integrated Data Review

Data Validation

Leadership

Data Visualization

Analytics

Risk-Based Data Management

Educación

Bachelor's degree in Life Sciences/Statistics/Computer Science

Herramientas

Data Review Tools

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks an Associate Director, Data Validation Strategy to lead the Integrated Data Review (IDR) strategy within Clinical Data Management.

You will shape the operating model, governance, and standards, ensuring high-quality, inspection-ready clinical data and collaboration across Biostatistics, Clinical Data Reporting, QISS, and study teams. The role emphasizes developing DRPs, KPI monitoring, and mentoring the Data Review and Quality team, while advancing