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Director, Integrated Data Quality
RegeneronRegeneron biotechnology director leading integrated data review across clinical programs. Establishing governance, risk-based data strategies, quality metrics, and inspection-ready data processes.
Posted 8/17/2026full-timeWarren • New Jersey, New York • 🇺🇸 United StatesLead💰 $183,100 - $305,200 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert knowledge in Clinical Data Management and Integrated Data Review principles, with a strong focus on data quality management and regulatory compliance. Proven ability to lead cross-functional teams and implement effective governance frameworks and methodologies in clinical programs.
Highest-signal resume keywords
Clinical Data ManagementIntegrated Data ReviewData Quality ManagementRegulatory CompliancePeople Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Review PlansRisk-Based Data ManagementGovernance FrameworksKPI DevelopmentData Quality MetricsClinical Data AnalysisSOP DevelopmentChange ManagementTraining Material DevelopmentData Visualization
Soft Skills
LeadershipStrategic ThinkingCollaborationInfluencing Without AuthorityProblem Solving
Industry Keywords
ICH E6 (R3)ICH E8 (R1)GxP21 CFR Part 11Global Data Privacy RegulationsRisk-Based Quality ManagementBiotechnologyPharmaceuticalHealth-Related IndustryIntegrated Data Review Methodologies
About the role
Key responsibilities & impact- Define and lead the Integrated Data Review strategy, operating model, and governance framework across the portfolio
- Oversee consistent execution of Data Review Plans and proactive identification of data quality risks
- Develop standardized data review plan methodologies, templates, processes, and guidance
- Monitor Data Review Plan execution through governance processes, KPIs, and quality metrics
- Partner with Clinical Data Reporting to develop and maintain standardized libraries of visualizations, listings, dashboards, and patient profiles
- Collaborate with the QISS team to translate Risk-Based Data Management methodologies into practical data review approaches and study-level requirements
- Identify data quality, integrity, and delivery-timeline risks and implement mitigation strategies
- Drive continuous improvement and innovation in integrated data review methodologies and technologies
- Develop and maintain SOPs, work instructions, templates, and training materials
- Lead implementation, change management, and training initiatives
- Drive adoption of integrated data review methodologies across clinical and external data domains
- Liaise with internal and external collaborators throughout the drug development process
Requirements
What you’ll need- 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 Risk-Based Data Management principles and their application to Integrated Data Review, including centralized monitoring activities
- Understanding of Risk-Based Quality Management principles and their relationship to integrated data review and centralized monitoring
- 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 trends and potential quality issues
- Experience developing, implementing, and overseeing Data Review Plans and associated governance processes
- 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
- Success solving complex business problems through strategic and critical thinking
- Ability to lead and influence within a matrix organization and drive alignment across cross-functional stakeholders without direct authority
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required