Regeneron · 9 hours ago
Director, Program Operations Leader - Early Phase Clinical Trials
Warren, NJ
Full-time
Hybrid
Director/Executive
12+ years expRegeneron is a biotechnology company focused on developing medicines for serious diseases. The Director Program Operations Leader is responsible for the leadership and strategic management of complex programs in Clinical Trial Management, overseeing clinical operations activities, timelines, and budgets while ensuring compliance with regulations and best practices.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Be responsible for the overall success of the clinical study team(s) within a program(s)
Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
Oversee clinical study timelines within a clinical program(s)
Provide input and operational insight into Clinical Study Concepts (CSC)
Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM
Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)
Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
Be responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
Qualification
Required
A Bachelor's degree
Minimum of 12 years relevant in-house sponsor-side industry experience
8 years within clinical operations
Benefits
Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off for eligible employees at all levels
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-13
2026-01-09
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