Associate Director, Data Validation Strategy

Regeneron

Confirmed live today High trust

Hybrid

Quick summary

Work type: Hybrid
Location: Warren, NJArmonkTarrytown, NY
Salary: $157,200–$256,600 / yr
Employment: Full-time
Posted: 5 days ago
Freshness: Confirmed live today
Nearby: 31 roles within 25 mi

Market check

Salary context

Competitive pay

How this pay compares to similar roles

Similar $208k

This role $207k

$144k $272k

below market most similar roles pay here above market

This role pays more than 51% of similar roles. Most pay $173,200–$242,912 — the blue band above. At the midpoint, this role pays about $207k versus about $208k for comparable roles.

Based on 240 similar postings.

Employer

About Regeneron

Regeneron is a leading science-driven biotechnology company that invents, develops, and commercializes life-transforming medicines for serious diseases.

Regeneron currently has 69 open roles on FindRole.

Listed pay typically runs $134,400–$241,200 across 55 roles with salary data.

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At a glance

TL;DR · Associate Director, Data Validation Strategy

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The Associate Director, Data Validation Strategy joins the Clinical Data Management organization to lead the strategy and execution of integrated data review. This role involves overseeing the development and quality of Data Review Plans, managing issue tracking, and ensuring clinical data is high-quality and inspection-ready. You will collaborate with Biostatistics, Clinical Data Reporting, and study teams to deliver risk-based data review aligned with critical-to-quality factors. Key responsibilities include monitoring performance through KPIs, developing SOPs, and driving innovation through automation and AI-enabled analytics. The position requires expertise in ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles. You will utilize data review tools, visualization, and analytics to proactively detect issues within clinical and external data domains.

Skills

Integrated Data Review Risk-Based Data Management RBDM RBQM GxP 21 CFR Part 11 ICH E6 ICH E8 Data Validation Analytics AI KPIs SOPs Clinical Data Management

What you'll do

Lead the implementation and execution of the Integrated Data Review (IDR) strategy, operating model, and governance.
Oversee the development, execution, and quality of Data Review Plans, including issue tracking and resolution.
Deliver risk-based data review aligned with critical-to-quality factors in partnership with Biostatistics and study teams.
Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement.
Develop 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 for data review.
Manage, mentor, and develop the Integrated Data Review and Quality team.

What we're looking for

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.
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.

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