Director, Program Operations Leader- Internal Medicine jobs in United States
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Regeneron · 4 months ago

Director, Program Operations Leader- Internal Medicine

Regeneron Pharmaceuticals is seeking a Director, Program Operations Leader for their Clinical Trial Management team. The role involves leading the operational strategy for complex clinical programs, ensuring quality, timelines, and budgets are met while managing a team and interacting with senior management and external partners.

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Comp. & Benefits
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H1B Sponsor Likelynote

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)
Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
Review 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)
Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
Act as point of contact for clinical program and study level escalation
Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
Provide proactive creation and implementation of risk mitigation strategies
Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
Drives the strategy and oversight for vendor selection and management within a clinical program(s)
Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
May require up to 25% travel

Qualification

Clinical Trial ManagementOperational Strategy DevelopmentBudget ManagementVendor ManagementRisk Mitigation StrategiesClinical Operations ExpertiseCoachingLeadershipMentoringCommunication SkillsProblem Solving

Required

Bachelor's degree
minimum of 12 years of related in-house sponsor-side pharmaceutical experience
8 years in clinical operations

Benefits

Health and wellness programs
Fitness centers
Equity awards
Annual bonuses
Paid time off

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

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 Company
Total Funding
$15.93M
Key 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

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase