About this opportunity
Regeneron Pharmaceuticals, Inc (USA) lists this Director, Program Operations Leader - Ophthalmology/Renal opportunity in armonk, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Location and Onsite Requirements: For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.
Role Overview: The Program Operations Leader (POL) leads the operational strategy for delivering one or more complex programs in Clinical Trial Management (CTM). This individual oversees clinical operations activities and decisions, including quality, timelines, and budgets, ensuring compliance with regulations (ICH/GCP) and company SOPs. The POL interacts with senior management, external vendors, collaboration partners, and clinical study personnel, and is a member of the Clinical Trial Management extended leadership team.
The POL line‑manages clinical trial management staff, including recruitment, development, coaching, mentoring, and performance management, and plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL operates with high independence and autonomy.
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, proactively communicate 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 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 provide clinical operations expertise during protocol design, feasibility, study start‑up and conduct phases
Ensure consistency within the program and develop best practices within CTM
Oversee clinical study budgets within a program: review, present, and approve the initial study budget and manage the budget throughout the program lifecycle by communicating changes to the TA Operations Leader as appropriate
Ensure timely delivery of quality operational deliverables and maintain consistency of process and approaches across clinical study teams within the program(s)
Drive decision‑making and integrate all operational considerations for studies within a 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 program(s) to track progress
Provide proactive creation and implementation of risk‑mitigation strategies
Provide innovative and flexible operational solutions and options to cross‑functional and development teams; assist in preparing scenarios for creative solutions to operational challenges
Drive the strategy and oversight for vendor selection and management within a program(s)
Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to program level deliverables and relationships with key CRO and vendor counterparts
Line‑manage clinical trial staff, including recruitment, coaching, mentoring, and performance management
Drive the functional strategy of Clinical Trial Management in partnership with Functional leadership
Travel Requirement: May require up to 25% travel.
Qualifications: Bachelor's degree and a minimum of 12 years of in‑house sponsor‑side pharmaceutical experience, with at least 8 years in clinical operations.
Health and wellness programs (medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (military and parental leave) for eligible employees at all levels
Salary Range (annually): $205,000.00 - $341,600.00
Equal Opportunity Employer
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 or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
#J-18808-Ljbffr
Worksite address
armonk, NY, 10504, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.