Director Integrated Data Quality

Regeneron Pharmaceuticals, Inc; Cambourne; Sur place; GBP 135 000 - 180 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Integrated Data Review

Data Quality Management

Risk-Based Data Management

Cross-functional Collaboration

Leadership & Mentoring

Description du poste

Build our future together:

The Director, Integrated Data Review provides strategic leadership for the development, implementation, and continuous improvement of integrated data review processes across clinical programs. In partnership with Biostatistics and cross-functional collaborators, this role establishes scalable frameworks, standards, and oversight models to enable proactive, risk-based identification of data issues and ensure high-quality, inspection-ready clinical data. The position drives consistent execution of Data Review Plans and promotes adoption of integrated data review practices across study teams.

When & where:

• Location: Warren NJ, Armonk NY, and TarryTown NY
• Work model/flexibility: on site 4 days a week
• Travel percentage: 10%

Discover your role:

• Define and lead the Integrated Data Review (IDR) strategy, including the implementation of an appropriate operating model, and governance framework across the portfolio.
• Accountable for consistent execution, oversight, and critical issue of Data Review Plans (DRPs), and proactive identification of data quality risks.
• Define minimum requirements and develop standardized data review plans methodologies, templates, processes, and guidance to enable consistent and effective execution across study teams.
• Provide oversight of data review plans execution through established governance processes, KPIs, and quality metrics to ensure consistency, effectiveness, adherence to standards, and continuous improvement across programs.
• Partner with the Clinical Data Reporting group to develop, implement, and maintain standardized libraries of data review outputs, including visualizations, listings, dashboards, and patient profiles, that support scalable and consistent execution of integrated data review processes across programs.
• Collaborate with Quantitative Innovation and Statistical Strategy (QISS) team to translate Risk-Based Data Management (RBDM) methodologies into practical data review approaches and study-level requirements.
• Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of departmental objectives.
• Drive continuous improvement and innovation in IDR methodologies and technologies through analysis of metrics, lessons learned, inspection observations, and evolving industry practices.
• Develop and maintain SOPs, work instructions, templates, and training materials using quality-by-design principles to support integrated data review processes.
• Lead implementation, change management, and training initiatives to ensure consistent adoption.
• Drive adoption of IDR methodologies across clinical and external data domains to support proactive issue detection and improved data quality outcomes.
• Liaise with internal and external collaborators to develop strong relationships and ensure effective cross-functional collaboration and communication with respect to deliverables and throughout drug development process.

This role requires:

• 12+ years in Clinical Data Management within within the biotechnology, pharmaceutical or health related industry. With 5+ years of people management, leadership, and mentoring
• Expert knowledge of clinical data management principles, processes, technologies and industry best practices.
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
• Deep understanding of regulatory requirements and industry standards, including ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and global data privacy regulations, with the ability to apply these in an operational setting.
• Working knowledge of RBDM principles and their application to Integrated Data Review, including centralized monitoring activities.
• Understanding of Risked Based Quality Management (RBQM) principles and their relationship to integrated data review and centralized monitoring.
• Demonstrated experience establishing, implementing, and evolving integrated data review frameworks, governance models, and methodologies across clinical programs.
• Experience identifying critical data and defining risk-based data review strategies.
• Experience interpreting and analyzing clinical, operational, and external data to identify data trends and potential quality issues.
• Experience developing, implementing, and overseeing Data Review Plans and associated governance processes.
• Demonstrated ability to partner with cross-functional collaborators to support risk-based and integrated data review approaches.
• Understanding of KPIs and quality metrics used to assess effectiveness and impact of integrated data review activities.
• Demonstrated success in solving complex business problems through strategic and critical thinking.
• Proven ability to lead and influence within a matrix organization, driving alignment and outcomes across cross-functional stakeholders without direct authority.