Regeneron is hiring a Director, Program Operations Leader to provide strategic leadership for the operational delivery of complex Internal Medicine clinical trial programs. This autonomous role within Clinical Trial Management (CTM) is responsible for setting and implementing operational strategy to ensure program success.
What You'll Do
- 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 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.
- 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.
- 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.
- 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 and vendor counterparts.
- Line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management.
- Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership.
What We're Looking For
- Bachelor's degree.
- Minimum of 12 years of related in-house sponsor-side pharmaceutical experience.
- 8 years in clinical operations.
Team & Environment
You will be a member of the Clinical Trial Management extended leadership team.
Benefits & Compensation
- Compensation: $202,000.00 - $336,600.00
- Health and wellness programs
- Fitness centers
- Stock rewards
- Annual bonuses
- Paid leave
Work Mode
This is a hybrid position based in Uxbridge, US or Dublin.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex; nationality; national or ethnic origin; civil status, age, citizenship status, membership of the traveler community, sexual orientation, disability, genetic information, familial status, marital status or registered partnership, pregnancy or parental status, gender identity, gender change, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
