Director, Integrated Data Quality & Strategy

Regeneron

Kentucky

On-site

USD 180,000 - 240,000

Full time

5 days ago

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Job summary

Regeneron is seeking a Director, Integrated Data Review to lead strategy, governance, and execution of integrated data review across clinical programs. You will drive standardized DRPs, establish risk-based data management practices, and collaborate with Biostatistics and study teams to ensure inspection-ready data.

You will build scalable libraries of outputs, define KPIs, and mentor teams to maintain quality and regulatory alignment across programs.

Qualifications

12+ years in Clinical Data Management within biopharma, with leadership experience.
Expert knowledge of integrated data review principles and data quality management.
Strong understanding of regulatory requirements (ICH, 21 CFR Part 11).
Proven ability to establish governance models and drive process improvements across programs.

Responsibilities

Define and lead the Integrated Data Review (IDR) strategy and operating model across portfolio.
Oversee Data Review Plans (DRPs) and data quality risk identification.
Develop standardized data review methodologies, templates, and guidance.
Provide governance oversight with KPIs and quality metrics for consistency.
Create libraries of data review outputs including visualizations and dashboards.
Partner with cross-functional teams to implement RBQ strategies and standardized data practices.