Director, Program Operations Leader - Ophthalmology/Renal

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 205,000 - 341,600; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

401(k) company match

Family support benefits

Equity awards

Annual bonuses

Paid time off

Paid leaves for eligible employees

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Program Operations Leader to lead the operational strategy for complex programs in Clinical Trial Management. This role oversees clinical operations activities, ensuring compliance with regulations while managing timelines and budgets.

The ideal candidate will possess a bachelor's degree and have at least 12 years of pharmaceutical experience, with 8 years focusing on clinical operations. The position is based in Armonk, New York, requiring on-site presence for 4 days a week.

Qualifications

• 12 years of in-house sponsor-side pharmaceutical experience.
• At least 8 years in clinical operations.

Responsibilities

• Lead operational strategy for complex programs in Clinical Trial Management.
• Oversee clinical operations activities ensuring compliance with regulations.
• Maintain program status and proactively communicate issues.

Skills

Clinical operations experience

Project management

Operational strategy development

Vendor management

Education

Bachelor's degree

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.