Associate Director, Data Validation Strategy & Innovation

BioSpace; New Jersey; Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director, Data Validation Strategy to lead the strategy and execution of integrated data review within Clinical Data Management. This role collaborates with Biostatistics, QISS, and study teams to ensure data quality and inspection readiness, with on-site work in Warren, NJ and hybrid flexibility.

The position emphasizes leadership, data governance, and implementing risk-based data review processes, along with driving automation and AI-enabled analytics in a

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science or related field.
• 10+ years in Clinical Data Management with 5+ years of leadership experience.
• Experience implementing IDR, quality management, risk-based data management, or centralized review processes.
• 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

IDR Strategy

Data Review

Leadership

Data Management

Education

Bachelor's degree

Life Sciences

Statistics

Computer Science

Tools

Data Visualization

Analytics Tools

Job description

Regeneron is seeking an Associate Director, Data Validation Strategy to lead the strategy and execution of integrated data review within Clinical Data Management. This role collaborates with Biostatistics, QISS, and study teams to ensure data quality and inspection readiness, with on-site work in Warren, NJ and hybrid flexibility.

The position emphasizes leadership, data governance, and implementing risk-based data review processes, along with driving automation and AI-enabled analytics in a