Director, Program Operations Leader - Ophthalmology/Renal
Regeneron
August 23, 2026
Remote friendly (Armonk, NY)
United States
Operations
The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM), including quality, timelines, and budgets in accordance with applicable regulations, ICH/GCP, and company SOPs.
In a Typical Day, You Will
- Be responsible for the overall success of clinical study team(s) within a program(s)
- Maintain oversight of program status and proactively communicate progress, risks, issues, and changes impacting quality, timelines, and/or budget
- Provide operational insight into feasibility, timeline, and cost estimates during development
- Oversee clinical study timelines within a program(s)
- Provide input and operational insight into Clinical Study Concepts (CSC)
- Develop and implement operational strategy; drive early study planning budget and timelines from CSC through Final Protocol
- Review plans and provide clinical operations expertise across protocol design, feasibility, start-up, and conduct; develop CTM best practices
- Oversee clinical study budgets; manage budget lifecycle and communicate changes to TA Operations Leader as appropriate
- Ensure timely delivery of quality operational deliverables and consistency across study teams
- Drive decision-making and integrate operational considerations to ensure goals are attainable prior to implementation
- Act as point of contact for program/study escalation
- Review key metrics and KPIs to track study progress
- Create and implement risk mitigation strategies
- Provide innovative operational solutions for cross-functional teams
- Lead strategy and oversight for vendor selection and management within a program(s)
- Manage CRO(s) and vendors for program-level deliverables
- May require up to 25% travel
Qualifications
- Bachelor’s degree
- Minimum 12 years of related in-house sponsor-side pharmaceutical experience
- 8 years in clinical operations
Application Instructions
- Apply now.
In a Typical Day, You Will
- Be responsible for the overall success of clinical study team(s) within a program(s)
- Maintain oversight of program status and proactively communicate progress, risks, issues, and changes impacting quality, timelines, and/or budget
- Provide operational insight into feasibility, timeline, and cost estimates during development
- Oversee clinical study timelines within a program(s)
- Provide input and operational insight into Clinical Study Concepts (CSC)
- Develop and implement operational strategy; drive early study planning budget and timelines from CSC through Final Protocol
- Review plans and provide clinical operations expertise across protocol design, feasibility, start-up, and conduct; develop CTM best practices
- Oversee clinical study budgets; manage budget lifecycle and communicate changes to TA Operations Leader as appropriate
- Ensure timely delivery of quality operational deliverables and consistency across study teams
- Drive decision-making and integrate operational considerations to ensure goals are attainable prior to implementation
- Act as point of contact for program/study escalation
- Review key metrics and KPIs to track study progress
- Create and implement risk mitigation strategies
- Provide innovative operational solutions for cross-functional teams
- Lead strategy and oversight for vendor selection and management within a program(s)
- Manage CRO(s) and vendors for program-level deliverables
- May require up to 25% travel
Qualifications
- Bachelor’s degree
- Minimum 12 years of related in-house sponsor-side pharmaceutical experience
- 8 years in clinical operations
Application Instructions
- Apply now.