Director, Program Operations Leader- Phase 4/RWE

Regeneron Pharmaceuticals; Armonk (NY); Hybrid; USD 202,000 - 337,000; Full time

Job summary

An established industry player seeks a Director of Program Operations Leader to guide complex clinical trial programs. This pivotal role involves strategic management, ensuring quality, timelines, and budgets align with regulations. You will lead clinical study teams, manage budgets, and drive decision-making while collaborating with senior management and external partners. Join a diverse culture that values inclusivity and offers comprehensive benefits, including wellness programs and equity awards. If you have a passion for clinical operations and a proven track record in the pharmaceutical industry, this is your chance to make a significant impact.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Bonuses

Paid time off

Qualifications

• 12+ years of experience in the pharmaceutical industry.
• 8+ years in clinical trial management preferred.

Responsibilities

• Oversee clinical operations activities and ensure quality and timelines.
• Manage clinical study budgets and deliverables across study teams.
• Drive decision-making and propose innovative operational solutions.

Skills

Clinical Trial Management

Leadership

Project Management

Budget Management

Risk Mitigation

Education

Bachelor's Degree

Job description

This role is on-site 4 days a week and 1 day from home.

The Director of Program Operations Leader (POL) is responsible for leadership and strategic management of complex programs in Clinical Trial Management (CTM). This individual oversees clinical operations activities, ensuring quality, timelines, and budgets align with regulations, ICH/GCP standards, and company SOPs within assigned programs. The Dir POL is a key member of the Clinical Trial Management extended leadership team, engaging with senior management, external vendors, partners, and clinical staff for project and departmental initiatives. The role includes line management of clinical trial staff, covering recruitment, development, coaching, mentoring, and performance management.

In a typical day, you will:

1. Be responsible for the overall success of the clinical study teams within a program.
2. Maintain an overview of program status, proactively communicate progress, risks, issues, or changes impacting quality, timelines, or budgets; provide updates to stakeholders.
3. Offer operational insights into feasibility, timelines, and cost estimates during study development.
4. Oversee clinical study timelines and provide input during protocol design, feasibility, startup, and conduct phases, ensuring best practices.
5. Review plans and provide clinical operations expertise throughout study phases.
6. Manage clinical study budgets, including review, approval, and lifecycle management.
7. Ensure timely delivery of operational deliverables and consistency across study teams.
8. Drive decision-making, integrating operational considerations to achieve study goals.
9. Serve as the point of contact for escalation at the program and study levels.
10. Review key metrics and KPIs to monitor progress.
11. Develop and implement risk mitigation strategies.
12. Propose innovative operational solutions to challenges.
13. Lead vendor selection and management, including CRO oversight and vendor relationships.

Qualifications include a Bachelor's degree and at least 12 years of relevant sponsor-side pharmaceutical industry experience, with 8 years in clinical trial management. Phase 4 and/or real-world evidence experience is highly preferred.

If this sounds like you, apply now to start your journey with Regeneron! We offer an inclusive, diverse culture with comprehensive benefits, including health and wellness programs, fitness centers, equity awards, bonuses, and paid time off.

Regeneron is an equal opportunity employer, providing consideration without regard to race, color, religion, sex, nationality, age, disability, and other protected characteristics. We accommodate known disabilities or chronic illnesses unless undue hardship occurs.

Salary ranges are specified for U.S., Japan, and Canada roles, with discussions available for other locations.

Background checks are part of the recruitment process, verifying information such as identity, work rights, and educational qualifications.

Salary Range (annually): $202,000.00 - $336,600.00