Director Program Operations Leader, Oncology

Overview

The Director Program Operations Leader (POL) leads the operational strategy for delivering complex clinical trials in the Oncology program. The POL oversees clinical operations activities, including quality, timelines, budgets, and compliance with ICH/GCP regulations and company SOPs across assigned programs.
Responsibilities

Ensure overall success of the clinical study teams within assigned programs.
Maintain an overview of program status and proactively communicate progress, risks, and changes that may impact quality, timelines, or budget.
Provide operational insight into feasibility, timelines, and cost estimates during program/study development.
Oversee study timelines and budgets, ensuring alignment with protocols and regulatory requirements.
Lead the development and implementation of the operational strategy from Clinical Study Concept through Final Protocol Review.
Ensure consistency in processes and best practices across study teams.
Drive decision-making, integrating operational considerations to meet study goals.
Act as point of contact for program and study-level escalation.
Review key metrics and KPIs to track study progress.
Create and implement risk mitigation strategies.
Develop innovative operational solutions and scenarios for cross-functional teams.
Oversee vendor selection, management, and relationships with CROs and other vendors.
Manage travel commitments, which may require up to 25% travel.
Qualifications

Bachelor’s degree required.
Minimum 12 years of in-house sponsor-side pharmaceutical experience, with at least 8 years in clinical operations.
Experience leading clinical trial management programs, managing budgets, and ensuring regulatory compliance.
Strong leadership and line management skills, including recruiting, coaching, and performance management.
Ability to work autonomously and independently while collaborating with senior leadership, external vendors, and clinical teams.
Experience with CRO management and vendor oversight in clinical research.
Benefits

Regeneron offers a comprehensive benefits package, including health and wellness programs, dental, vision, and life insurance, fitness centers, 401(k) match, family support, equity awards, annual bonuses, paid time off, and family leave. For additional information about benefits in the United States, please consult the Regeneron Careers website.
EEO Statement

Regeneron is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Regeneron will provide reasonable accommodation to qualified applicants with disabilities unless doing so would impose an undue hardship.

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