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About the Role
The Director, Integrated Data Review provides strategic leadership for the development, implementation, and continuous improvement of integrated data review processes across clinical programs. 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Requirements
- 12+ years in Clinical Data Management within the biotechnology, pharmaceutical or health related industry.
- 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.
- 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.
Skills
- Integrated Data Review (IDR)
- Data Review Plans (DRPs)
- Risk-Based Data Management (RBDM)
- Risked Based Quality Management (RBQM)
- Clinical Data Management
- Data Quality Management
- ICH E6 (R3)
- ICH E8 (R1)
- GxP
- 21 CFR Part 11
- Global data privacy regulations
- Centralized monitoring
- KPIs
- Quality metrics
- Change management
- Training
- SOPs
- Work instructions
- Templates
- People management
- Leadership
- Mentoring
Location
- Warren NJ
- Armonk NY
- TarryTown NY
Work Type
- On-site
- Full-time
Experience Level
- Director
- 12+ years in Clinical Data Management
- 5+ years of people management, leadership, and mentoring
Salary/Compensations
- $183,100.00 - $305,200.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.