Director, Integrated Data Quality & Review

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Health benefits

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a Director to lead Integrated Data Review (IDR) strategy and governance across clinical programs, ensuring scalable data review practices and inspection-ready data. You will partner with Biostatistics, QISS, and study teams to standardize plans and outputs.

You will drive approaches that improve data quality, develop SOPs, and mentor teams while advancing IDR methodologies across programs.

Qualifications

• 12+ years in Clinical Data Management in biotech/pharma
• 5+ years of people management and mentoring
• Expert knowledge of CDM principles, data quality and RBQM
• Understanding of regulatory requirements (ICH E6 R3, ICH E8 R1, 21 CFR Part 11) and data privacy

Responsibilities

• Define and lead the Integrated Data Review (IDR) strategy, governance, and operating model across the portfolio.
• Develop standardized data review plans, templates, and guidance for consistent execution across study teams.
• Oversee DRP execution using governance processes, KPIs, and quality metrics to ensure data quality and timeliness.
• Collaborate with Clinical Data Reporting and QISS to implement risk-based data review approaches across programs

Skills

Data management

Leadership

Regulatory knowledge

RBDM principles

Cross-functional collaboration

Education

Life sciences degree

Job description

Regeneron Pharmaceuticals, Inc (USA) seeks a Director to lead Integrated Data Review (IDR) strategy and governance across clinical programs, ensuring scalable data review practices and inspection-ready data. You will partner with Biostatistics, QISS, and study teams to standardize plans and outputs.

You will drive approaches that improve data quality, develop SOPs, and mentor teams while advancing IDR methodologies across programs.