Director of Integrated Data Quality & Governance

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 135,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Director to provide strategic leadership for integrated data review across clinical programs.

You will define IDR strategy, establish governance, and drive standardized data review practices with cross-functional teams to enable proactive data issue identification and inspection-ready data. You will oversee DRPs, develop standardized templates, and lead adoption of IDR methodologies across study teams, partnering with QISS and Clinical Data Reporting.

Qualifications

• 12+ years in Clinical Data Management within biotechnology, pharmaceutical, or health-related industries.
• 5+ years in people management, leadership, and mentoring.
• Expert knowledge of clinical data management principles, processes, and industry best practices.
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
• Understanding regulatory requirements (ICH E6(R3), ICH E8(R1), GxP, 21 CFR Part 11).

Responsibilities

• Define and lead the Integrated Data Review (IDR) strategy and governance across the portfolio.
• Ensure consistent execution and proactive identification of data quality risks via DRPs.
• Develop standardized data review plans methodologies, templates, and guidance for study teams.
• Oversee data review plans execution through governance processes, KPIs, and quality metrics.
• Collaborate with Clinical Data Reporting to develop libraries of data review outputs (visualizations, listings, dashboards).
• Partner with QISS to translate Risk-Based Data Management into practical data review approaches.
• Identify risks to data quality and delivery timelines and implement mitigation strategies.
• Drive continuous improvement and innovation in IDR methodologies and technologies.
• Develop SOPs, work instructions, templates, and training materials; lead training initiatives.
• Drive adoption of IDR methodologies across clinical and external data domains; liaise with collaborators.

Skills

Integrated Data Review

Data Quality Management

Risk-Based Data Management

Cross-functional Collaboration

Leadership & Mentoring

Job description

Regeneron Pharmaceuticals, Inc. seeks a Director to provide strategic leadership for integrated data review across clinical programs.

You will define IDR strategy, establish governance, and drive standardized data review practices with cross-functional teams to enable proactive data issue identification and inspection-ready data. You will oversee DRPs, develop standardized templates, and lead adoption of IDR methodologies across study teams, partnering with QISS and Clinical Data Reporting.