Director, 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

Build our future together:

The Director, Integrated Data Review provides strategic leadership for the development, implementation, and continuous improvement of integrated data review processes across clinical programs. In partnership with Biostatistics and cross-functional collaborators, this role establishes scalable frameworks, standards, and oversight models to enable proactive, risk-based identification of data issues and ensure high-quality, inspection-ready clinical data. The position drives consistent execution of Data Review Plans and promotes adoption of integrated data review practices across study teams.

When & where:

• Location: Warren NJ, Armonk NY, and TarryTown NY
• Work model/flexibility: on site 4 days a week
• Travel percentage: 10%

Discover your role:

• Define and lead the Integrated Data Review (IDR) strategy, including the implementation of an appropriate operating model, and governance framework across the portfolio.
• Accountable for consistent execution, oversight, and critical issue of Data Review Plans (DRPs), and proactive identification of data quality risks.
• Define minimum requirements and develop standardized data review plans methodologies, templates, processes, and guidance to enable consistent and effective execution across study teams.
• Provide oversight of data review plans execution through established governance processes, KPIs, and quality metrics to ensure consistency, effectiveness, adherence to standards, and continuous improvement across programs.
• Partner with the Clinical Data Reporting group to develop, implement, and maintain standardized libraries of data review outputs, including visualizations, listings, dashboards, and patient profiles, that support scalable and consistent execution of integrated data review processes across programs.
• Collaborate with Quantitative Innovation and Statistical Strategy (QISS) team to translate Risk-Based Data Management (RBDM) methodologies into practical data review approaches and study-level requirements.
• Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of departmental objectives.
• Drive continuous improvement and innovation in IDR methodologies and technologies through analysis of metrics, lessons learned, inspection observations, and evolving industry practices.
• Develop and maintain SOPs, work instructions, templates, and training materials using quality-by-design principles to support integrated data review processes.
• Lead implementation, change management, and training initiatives to ensure consistent adoption.
• Drive adoption of IDR methodologies across clinical and external data domains to support proactive issue detection and improved data quality outcomes.
• Liaise with internal and external collaborators to develop strong relationships and ensure effective cross-functional collaboration and communication with respect to deliverables and throughout drug development process.

This role requires:

• 12+ years in Clinical Data Management within within the biotechnology, pharmaceutical or health related industry. With 5+ years of people management, leadership, and mentoring
• Expert knowledge of clinical data management principles, processes, technologies and industry best practices.
• Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
• Deep understanding of regulatory requirements and industry standards, including ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and global data privacy regulations, with the ability to apply these in an operational setting.
• Working knowledge of RBDM principles and their application to Integrated Data Review, including centralized monitoring activities.
• Understanding of Risked Based Quality Management (RBQM) principles and their relationship to integrated data review and centralized monitoring.
• Demonstrated experience establishing, implementing, and evolving integrated data review frameworks, governance models, and methodologies across clinical programs.
• Experience identifying critical data and defining risk-based data review strategies.
• Experience interpreting and analyzing clinical, operational, and external data to identify data trends and potential quality issues.
• Experience developing, implementing, and overseeing Data Review Plans and associated governance processes.
• Demonstrated ability to partner with cross-functional collaborators to support risk-based and integrated data review approaches.
• Understanding of KPIs and quality metrics used to assess effectiveness and impact of integrated data review activities.
• Demonstrated success in solving complex business problems through strategic and critical thinking.
• Proven ability to lead and influence within a matrix organization, driving alignment and outcomes across cross-functional stakeholders without direct authority.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$183,100.00 - $305,200.00