Director, Integrated Data Quality & Risk Oversight

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

Job summary

Regeneron seeks a Director, Integrated Data Review to provide strategic leadership for data review across clinical programs. You will establish scalable governance, enable proactive data issue identification, and ensure inspection-ready data in collaboration with Biostatistics and cross-functional teams.

Location includes Warren NJ, Armonk NY, and TarryTown NY with onsite work four days a week and travel about 10%.

Qualifications

• 12+ years in Clinical Data Management within biotechnology, pharmaceutical or health industries.
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
• Deep regulatory knowledge incl. ICH E6 (R3), ICH E8 (R1), 21 CFR Part 11, and global data privacy.
• Working knowledge of RBDM principles and centralized monitoring.
• Understanding RBQM principles and their application to IDR and centralized monitoring.
• Experience establishing and evolving IDR frameworks, governance models, and methodologies.
• Experience identifying critical data and defining risk-based data review strategies.
• Ability to interpret and analyze clinical, operational, and external data to identify trends and issues.
• Experience developing, implementing, and overseeing Data Review Plans and governance processes.
• Proven ability to partner with cross-functional collaborators in a matrix organization.
• Understanding of KPIs and quality metrics used to assess IDR effectiveness.
• Proven leadership and influence within cross-functional teams.

Responsibilities

• Define and lead the IDR strategy, including operating model and governance across the portfolio.
• Accountable for execution, oversight, and proactive identification of data quality risks in DRPs.
• Define minimum requirements and develop standardized DRP methodologies, templates, and guidance.
• Provide oversight of DRP execution through governance processes and KPIs.
• Develop and maintain standardized libraries of IDR outputs (visualizations, listings, dashboards).
• Collaborate with QISS to translate RBM methodologies into data review approaches.
• Identify risks to data quality and delivery timelines and implement mitigation strategies.
• Drive continuous improvement and innovation in IDR methodologies and technologies.
• Develop SOPs, training materials, and change-management plans to ensure adoption.
• Lead implementation and training initiatives to ensure adoption of IDR practices across domains.
• Liaise with internal/external teams to foster cross-functional collaboration and communication.

Skills

Clinical data management

Integrated data review

Data quality management

Regulatory knowledge

RBDM

RBQM

Data review frameworks

Risk-based data review

Data analysis

Data Review Plans

Cross-functional collaboration

KPIs & metrics

Leadership

Job description

Regeneron seeks a Director, Integrated Data Review to provide strategic leadership for data review across clinical programs. You will establish scalable governance, enable proactive data issue identification, and ensure inspection-ready data in collaboration with Biostatistics and cross-functional teams.

Location includes Warren NJ, Armonk NY, and TarryTown NY with onsite work four days a week and travel about 10%.