Associate Director, Data Validation Strategy

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 157,000 - 257,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director, Data Validation Strategy to lead the Integrated Data Review (IDR) strategy within Clinical Data Management.

You will shape the operating model, governance, and standards, ensuring high-quality, inspection-ready clinical data and collaboration across Biostatistics, Clinical Data Reporting, QISS, and study teams. The role emphasizes developing DRPs, KPI monitoring, and mentoring the Data Review and Quality team, while advancing

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science or related field.
• 10+ years of Clinical Data Management experience in biotech/pharma/healthcare.
• 5+ years of people, team, and project leadership experience.

Responsibilities

• Lead the implementation and execution of the Integrated Data Review (IDR) strategy, operating model, standards, and governance.
• Oversee the development, execution, and quality of Data Review Plans (DRPs), including issue tracking, escalation, and resolution.
• Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams delivering risk-based data review aligned with critical-to-quality factors.
• Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement.
• Support the development of SOPs, work instructions, templates, and training materials for IDR activities.
• Lead training, coaching, and change management to drive adoption of IDR across clinical and external data domains.
• Drive innovation, automation, and AI-enabled analytics initiatives.
• Manage, mentor, and develop the Integrated Data Review and Quality team.

Skills

Integrated Data Review

Data Validation

Leadership

Data Visualization

Analytics

Risk-Based Data Management

Education

Bachelor's degree in Life Sciences/Statistics/Computer Science

Tools

Data Review Tools

Job description

Build our future together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Data Validation Strategy join our Clinical Data Management organization, leading the strategy and execution of integrated data review, helping ensure our clinical data is high-quality and inspection-ready. You will collaborate with Biostatistics, Clinical Data Reporting, Quantitative Innovation and Statistical Strategy (QISS), and study teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where

• Location: Warren, NJ, Armonk or Tarrytown, NY
• Work model: Primarily on-site with hybrid flexibility
• Travel percentage: Up to 25%

Discover your role

• Lead the implementation and execution of the Integrated Data Review (IDR) strategy, operating model, standards, and governance
• Oversee the development, execution, and quality of Data Review Plans (DRPs), including issue tracking, escalation, and resolution
• Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams delivering risk-based data review aligned with critical-to-quality factors
• Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement
• Support the development of SOPs, work instructions, templates, and training materials for IDR activities
• Lead training, coaching, and change management to drive adoption of IDR across clinical and external data domains
• Drive innovation, automation, and AI-enabled analytics initiatives
• Manage, mentor, and develop the Integrated Data Review and Quality team

This role requires

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
• 10+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or healthcare industry and 5+ years of people, team, and project leadership experience
• Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes
• Strong working knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles
• Experience supporting inspection readiness activities
• Experience with data review tools, visualization, and analytics for proactive issue detection

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.

Salary Range (annually) $157,200.00 - $256,600.00

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
• 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.