Director, Integrated Data Quality & Strategy

Regeneron; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking a Director, Integrated Data Review to provide strategic leadership for data review across clinical programs. You will establish scalable operating models, governance, and standards to enable proactive identification of data issues and high-quality, inspection-ready data.

You will collaborate with Biostatistics and cross-functional teams, drive continuous improvement, develop SOPs and training, and ensure adoption of IDR practices across study teams and external data domains.

Qualifications

• 12+ years in Clinical Data Management within biotechnology, pharmaceutical or health-related industry.
• 5+ years of 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), 21 CFR Part 11) and RBQM/RBDM concepts.

Responsibilities

• Define and lead the Integrated Data Review (IDR) strategy, including operating model and governance framework across the portfolio.
• Accountable for execution and oversight of Data Review Plans and proactive identification of data quality risks.
• Develop standardized data review methodologies, templates, processes, and guidance for study teams.
• Oversee data review plan execution through governance, KPIs and quality metrics to ensure consistency and continuous improvement.
• Collaborate with Clinical Data Reporting to build libraries of data review outputs (visualizations, listings, dashboards, patient profiles).
• Partner with QISS to translate RBM into practical data review approaches.
• Identify risks to data quality and delivery timelines and implement mitigation strategies.
• Lead training and change management to ensure adoption of IDR methodologies.

Skills

Leadership

Clinical Data Management

Regulatory knowledge

Data review governance

Cross-functional collaboration

Job description

Regeneron is seeking a Director, Integrated Data Review to provide strategic leadership for data review across clinical programs. You will establish scalable operating models, governance, and standards to enable proactive identification of data issues and high-quality, inspection-ready data.

You will collaborate with Biostatistics and cross-functional teams, drive continuous improvement, develop SOPs and training, and ensure adoption of IDR practices across study teams and external data domains.