Director, Integrated Data Quality — On‑Site 4 Days/Week

Regeneron; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking aSenior leader to define and drive Integrated Data Review (IDR) strategy across clinical programs. You will establish governance, templates, and KPIs to ensure proactive data quality and inspection-readiness.

Lead cross-functional collaborations with Biostatistics and QISS to translate RBQM into practical data review approaches, while mentoring teams and advancing IDR frameworks across study portfolios.

Qualifications

• 12+ years in Clinical Data Management with 5+ years in people leadership.
• Expert knowledge of CDM principles, processes, technologies and industry best practices.
• Deep understanding of regulatory requirements (ICH E6, ICH E8, 21 CFR Part 11) and RBQM/RBDM concepts.

Responsibilities

• Define and lead Integrated Data Review strategy and governance.
• Ensure consistent execution of Data Review Plans with quality metrics.
• Develop standardized data review methodologies and templates.
• Oversee data review plan execution through governance processes and KPIs.
• Collaborate with cross-functional teams to scale IDR across programs.

Skills

Leadership

Strategic thinking

Data management

Cross-functional collaboration

Tools

ICH guidelines

GxP awareness

Job description

Regeneron is seeking aSenior leader to define and drive Integrated Data Review (IDR) strategy across clinical programs. You will establish governance, templates, and KPIs to ensure proactive data quality and inspection-readiness.

Lead cross-functional collaborations with Biostatistics and QISS to translate RBQM into practical data review approaches, while mentoring teams and advancing IDR frameworks across study portfolios.