Director, Integrated Data Review & Quality

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

Job summary

Regeneron seeks a Director of Integrated Data Review to provide strategic leadership for developing, implementing, and continuously improving integrated data review processes across clinical programs in partnership with Biostatistics and cross‑functional collaborators.

The role establishes scalable frameworks, governance models, and data review plans to enable proactive, risk‑based identification of data quality issues and to ensure inspection‑ready data across study teams.

Qualifications

• 12+ years in Clinical Data Management within the biotechnology, pharmaceutical or health-related industry.
• 5+ years of people management, leadership, and mentoring.
• Expert knowledge of integrated data review principles and data quality management.
• Strong understanding of regulatory requirements including ICH E6(R3), ICH E8(R1), 21 CFR Part 11.

Responsibilities

• Define and lead the Integrated Data Review strategy with operating model and governance across the portfolio.
• Oversee Data Review Plans, ensure execution, identification of data quality risks, and continuous improvement.
• Develop standardized data review plan methodologies, templates, processes, and guidance for study teams.
• Lead SOPs, work instructions, templates, and training materials using quality-by-design principles.
• Lead adoption of IDR methodologies across clinical and external data domains to improve data quality outcomes.
• Collaborate with cross-functional teams to ensure effective communication and delivery of objectives.

Skills

CDM leadership

Regulatory knowledge

Data quality mgmt

RBQM understanding

Job description

Regeneron seeks a Director of Integrated Data Review to provide strategic leadership for developing, implementing, and continuously improving integrated data review processes across clinical programs in partnership with Biostatistics and cross‑functional collaborators.

The role establishes scalable frameworks, governance models, and data review plans to enable proactive, risk‑based identification of data quality issues and to ensure inspection‑ready data across study teams.