Associate Director, Data Validation Strategy

Regeneron

. Lead the implementation and execution of the Integrated Data Review strategy, operating model, standards, and governance .

Posted 10/6/2026full-timeUnited StatesSenior💰 $157,200 - $256,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Integrated Data Review strategy implementation, quality management, and risk-based data management within the biotechnology and pharmaceutical sectors. Proven ability to lead teams, develop training materials, and drive innovation through automation and analytics.

Highest-signal resume keywords

Integrated Data Review ImplementationClinical Data ManagementLeadership ExperienceKnowledge of ICH E6 (R3) and GxPData Review Tools and Analytics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementIntegrated Data ReviewQuality ManagementRisk-Based Data ManagementData Review Plans DevelopmentKPI MonitoringIssue TrackingChange ManagementTraining DevelopmentAutomation Initiatives

Soft Skills

Team LeadershipCoachingCollaborationCommunicationMentoring

Tools & Technologies

Data Review ToolsVisualization ToolsAnalytics Platforms

Industry Keywords

BiotechnologyPharmaceuticalHealthcareICH E8 (R1)21 CFR Part 11RBDM/RBQM PrinciplesInspection Readiness

About the role

Key responsibilities & impact

Lead the implementation and execution of the Integrated Data Review strategy, operating model, standards, and governance
Oversee the development, execution, and quality of Data Review Plans, including issue tracking, escalation, and resolution
Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams to deliver risk-based data review aligned with critical-to-quality factors
Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement
Support the development of SOPs, work instructions, templates, and training materials for Integrated Data Review activities
Lead training, coaching, and change management to drive adoption of Integrated Data Review across clinical and external data domains
Drive innovation, automation, and AI-enabled analytics initiatives
Manage, mentor, and develop the Integrated Data Review and Quality team
Collaborate across Clinical Data Management, Biostatistics, Clinical Data Reporting, QISS, and study teams

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
10+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or healthcare industry
5+ years of people, team, and project leadership experience
Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes
Strong working knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles
Experience supporting inspection readiness activities
Experience with data review tools, visualization, and analytics for proactive issue detection
Willingness to work primarily on-site with hybrid flexibility
Ability to travel up to 25%

Benefits

Comp & perks

Hybrid flexibility
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