Regeneron

H1B Visa Sponsor Biotechnology Healthcare Manufacturing

Regeneron is a biotechnology company that discovers, develops, and commercializes medicines for serious and underserved conditions. Its research spans allergy, cardiovascular and metabolic disease, neuroscience, oncology, hematology, ophthalmology, and rare diseases. By combining biological research with advanced technology, Regeneron works on biologics and genetic medicines designed to address complex healthcare needs. The company also highlights health equity, environmental responsibility, scientific education, and ethical corporate practices as part of its broader mission to advance patient care.

Company Jobs

Associate Director, Data Validation Strategy — Regeneron Hybrid

Lead Regeneron’s clinical data validation and integrated data review strategy in a hybrid Associate Director role. Drive inspection-ready quality, risk-based review, analytics, and team development.

5 days ago

United States

New Jersey

New York

$157,200 – $256,600 / year

Hybrid Full-time Senior English Required Director

Description

Own the implementation and delivery of the Integrated Data Review strategy, operating model, standards, and governance.
Oversee Data Review Plan development, execution, quality, issue tracking, escalation, and resolution.
Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams on risk-based reviews aligned with critical-to-quality factors.
Use KPIs and quality metrics to monitor performance, identify trends, and advance continuous improvement.
Help create SOPs, work instructions, templates, and training resources for Integrated Data Review activities.
Lead training, coaching, and change management to increase adoption across clinical and external data domains.
Advance innovation, automation, and AI-enabled analytics initiatives.
Manage, mentor, and develop the Integrated Data Review and Quality team.
Work cross-functionally with Clinical Data Management, Biostatistics, Clinical Data Reporting, QISS, and study teams.

Requirements

Bachelor’s degree in life sciences, statistics, computer science, or a related discipline.
At least 10 years of Clinical Data Management experience in biotechnology, pharmaceuticals, or healthcare.
At least 5 years of experience leading people, teams, and projects.
Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes.
Strong knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles.
Experience supporting inspection-readiness activities.
Experience using data review, visualization, and analytics tools to identify issues proactively.
Willingness to work primarily on site with hybrid flexibility.
Ability to travel up to 25%.

Benefits

Hybrid work flexibility.
Annual bonuses or other incentive opportunities.
Equity awards.
Pension or retirement benefits.
401(k) company matching.
Health and wellness programs.
On-site fitness centers.
Medical, dental, vision, life, and disability insurance.
Paid time off.
Family support benefits.
Reasonable recruitment-process accommodations where required.

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Associate Director, Data Validation Strategy — Regeneron Hybrid

Lead Regeneron’s clinical data validation and integrated data review strategy in a hybrid Associate Director role. Drive inspection-ready quality, risk-based review, analytics, and team development.

Description

Requirements

Benefits

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