Head of Integrated Data Review & Quality

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

Job summary

Regeneron Pharmaceuticals, Inc. in Warren, NJ and nearby sites seeks a Director, Integrated Data Review to lead strategy, operating model, and governance for integrated data review across clinical programs. You will drive Data Review Plans, standardize methodologies, and assemble libraries of outputs to support scalable execution.

Collaboration with QISS will translate RBM into study-level requirements. Travel ~10%.

Qualifications

• 12+ years in Clinical Data Management within biotechnology, pharmaceutical or health industry.
• 5+ years of people management, leadership, and mentoring.
• Expert knowledge of clinical data management principles, processes, technologies and best practices.
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
• Regulatory knowledge including ICH E6(R3), ICH E8(R1), GxP, 21 CFR Part 11, and global data privacy.

Responsibilities

• Define and lead the Integrated Data Review strategy, including a governance framework across the portfolio.
• Accountable for Data Review Plans execution, oversight, and proactive data quality risk identification.
• Define minimum requirements and develop standardized DRP methodologies, templates, processes and guidance.
• Provide oversight of DRP execution through governance, KPIs, and quality metrics.
• Partner with Clinical Data Reporting to develop libraries of data review outputs (visualizations, listings, dashboards).
• Collaborate with QISS to translate RBM to practical data review approaches and study-level requirements.
• Identify potential risks to data quality and delivery timelines and implement mitigation strategies.
• Drive continuous improvement in IDR methodologies and technologies; develop SOPs and training materials.

Skills

Clinical Data Management

People management

Data quality management

RBDM

Integrated data review

Job description

Regeneron Pharmaceuticals, Inc. in Warren, NJ and nearby sites seeks a Director, Integrated Data Review to lead strategy, operating model, and governance for integrated data review across clinical programs. You will drive Data Review Plans, standardize methodologies, and assemble libraries of outputs to support scalable execution.

Collaboration with QISS will translate RBM into study-level requirements. Travel ~10%.