Director, Program Operations Leader - Ophthalmology/Renal
Regeneron
4 hours ago
On-site
Armonk, NY
Operations
Program Operations Leader (POL)
Responsibilities
- Lead delivery of one or more complex programs in Clinical Trial Management (CTM) by setting and implementing operational strategy
- Drive clinical operations activities and decisions covering quality, timelines, and budgets in accordance with applicable regulations, ICH/GCP, and SOPs
- Ensure overall success of clinical study team(s) within a program(s)
- Maintain oversight of clinical program status, proactively communicate progress/risks/issues/changes, and provide updates to stakeholders
- Provide operational insight into feasibility, timeline, and cost estimates during program/study development
- Oversee clinical study timelines and provide input on Clinical Study Concepts (CSC)
- Develop and implement operational strategy, including early study planning budget and timelines from CSC through Final Protocol
- Provide clinical operations expertise during protocol design, feasibility, study start-up, and conduct; ensure program consistency and CTM best practices
- Oversee clinical study budgets across the program lifecycle; manage and communicate budget changes as appropriate
- Ensure timely delivery of quality operational deliverables and consistency of processes/approaches across study teams
- Integrate operational considerations to ensure goals are attainable prior to implementation; drive decision-making
- Serve as point of contact for clinical program/study-level escalation
- Review key metrics and KPIs to track study progress
- Create and implement risk mitigation strategies
- Provide innovative, flexible operational solutions to cross-functional/development teams
- Lead vendor selection strategy and oversight; manage CRO/vendor relationships and program-level deliverables
- Line manage clinical trial management staff (including AD POL): recruitment, development, coaching, mentoring, and performance management
Qualifications
- Bachelor’s degree
- Minimum of 12 years related in-house sponsor-side pharmaceutical experience, including 8 years in clinical operations
Benefits
- In the U.S., benefits may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; equity awards; annual bonuses; paid time off; and paid leaves (e.g., military and parental leave)
Application Instructions
- Apply now.
Responsibilities
- Lead delivery of one or more complex programs in Clinical Trial Management (CTM) by setting and implementing operational strategy
- Drive clinical operations activities and decisions covering quality, timelines, and budgets in accordance with applicable regulations, ICH/GCP, and SOPs
- Ensure overall success of clinical study team(s) within a program(s)
- Maintain oversight of clinical program status, proactively communicate progress/risks/issues/changes, and provide updates to stakeholders
- Provide operational insight into feasibility, timeline, and cost estimates during program/study development
- Oversee clinical study timelines and provide input on Clinical Study Concepts (CSC)
- Develop and implement operational strategy, including early study planning budget and timelines from CSC through Final Protocol
- Provide clinical operations expertise during protocol design, feasibility, study start-up, and conduct; ensure program consistency and CTM best practices
- Oversee clinical study budgets across the program lifecycle; manage and communicate budget changes as appropriate
- Ensure timely delivery of quality operational deliverables and consistency of processes/approaches across study teams
- Integrate operational considerations to ensure goals are attainable prior to implementation; drive decision-making
- Serve as point of contact for clinical program/study-level escalation
- Review key metrics and KPIs to track study progress
- Create and implement risk mitigation strategies
- Provide innovative, flexible operational solutions to cross-functional/development teams
- Lead vendor selection strategy and oversight; manage CRO/vendor relationships and program-level deliverables
- Line manage clinical trial management staff (including AD POL): recruitment, development, coaching, mentoring, and performance management
Qualifications
- Bachelor’s degree
- Minimum of 12 years related in-house sponsor-side pharmaceutical experience, including 8 years in clinical operations
Benefits
- In the U.S., benefits may include medical, dental, vision, life, and disability insurance; fitness centers; 401(k) company match; equity awards; annual bonuses; paid time off; and paid leaves (e.g., military and parental leave)
Application Instructions
- Apply now.