Associate Director, Data Validation Strategy

BioSpace; New Jersey; Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director, Data Validation Strategy to lead the strategy and execution of integrated data review within Clinical Data Management. This role collaborates with Biostatistics, QISS, and study teams to ensure data quality and inspection readiness, with on-site work in Warren, NJ and hybrid flexibility.

The position emphasizes leadership, data governance, and implementing risk-based data review processes, along with driving automation and AI-enabled analytics in a

Qualifications

• Bachelor's degree in Life Sciences, Statistics, Computer Science or related field.
• 10+ years in Clinical Data Management with 5+ years of leadership experience.
• Experience implementing IDR, quality management, risk-based data management, or centralized review processes.
• Experience with data review tools, visualization, and analytics for proactive issue detection.

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

IDR Strategy

Data Review

Leadership

Data Management

Education

Bachelor's degree

Life Sciences

Statistics

Computer Science

Tools

Data Visualization

Analytics 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.

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)

$157,200.00 - $256,600.00