Director Program Operations Leader

Regeneron Pharmaceuticals, Inc.; Armonk, Cambridge (NY, MA); Hybrid; AUD 302,000 - 504,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director Clinical Trial Management Program Operations Leader to drive operational strategy for complex clinical programs within a hybrid U.S. work setup.

You will collaborate with senior leaders, vendors, and study teams to ensure timely, within-budget delivery. The role requires extensive experience in clinical operations, budgeting, scheduling, and resource management, with a focus on oversight of CROs and external partners and ensuring inspection

Qualifications

• Bachelor's degree mandatory; advanced degree may substitute for experience.
• Minimum 12 years of relevant proven experience, with at least 8 years in clinical operations.
• Knowledge of ICH/GCP, SOPs and regulatory requirements.
• Experience leading CROs, vendors and external partners.
• Ability to communicate effectively with senior management and cross-functional teams.

Responsibilities

• Lead operational strategy and delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide input to CST concepts, feasibility, timelines and cost estimates.
• Review plans during protocol design, startup and conduct.
• Drive decisions, monitor KPIs and implement risk mitigation.
• Lead vendor selection, CRO oversight, governance activities and partner meetings.
• Ensure inspection readiness and support for Regulatory Authority inspections.

Skills

Program leadership

Executive communication

Staff leadership

Resource forecasting

Budget & timelines management

Regulatory oversight

Vendor management

Governance & committees

Education

Bachelor's degree

Advanced degree (e.g., PhD/MD) may substitute for experience

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director Clinical Trial Management Program Operations Leader to join our Clinical Trial Management team, supporting our clinical development organization in a hybrid work mode. In this role, you will lead operational strategy and delivery for complex clinical programs while collaborating with senior leaders, vendors, collaboration partners, and clinical study teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location and Work Arrangement

US - Armonk, Warren or Cambridge - Hybrid (3 days in the office)

Key Responsibilities

• Lead operational strategy and overall delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide operational input to Clinical Study Concepts, feasibility, timelines, and cost estimates.
• Review plans during protocol design, study startup, and study conduct.
• Drive decisions, monitor KPIs, and implement risk mitigation strategies.
• Lead vendor selection, CRO oversight, governance activities, and partner meetings.
• Ensure inspection readiness and lead cross-functional support for Regulatory Authority inspections.

Required Experience & Qualifications

• Bachelor's degree.
• Advanced degree may be considered in lieu of proven experience.
• Minimum 12 years of relevant proven experience.
• Minimum 8 years of experience within clinical operations.
• Knowledge of applicable regulations, International Council for Harmonisation/Good Clinical Practice (ICH/GCP), and SOPs.
• Experience leading complex clinical programs and handling operational strategy, budgets, timelines, and resources.
• Experience forecasting and allocating Clinical Trial Management resources across programs.
• Experience managing Clinical Research Organizations (CROs), vendors, and external partners.
• Experience representing Clinical Trial Management at review committees and governance meetings.
• Experience leading staff recruitment, performance management, development, coaching, mentoring, training, and compliance activities.
• Ability to communicate effectively with senior management, partners, and cross-functional teams.

Benefits & Compensation

Salary Range (annually) $205,000.00 - $341,600.00

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

Equal Opportunity & Inclusion

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Company Overview

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award-winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Company Culture

We are committed to building a workplace with an inclusive culture.

On-Site Expectations

Please be advised that at Regeneron, we believe we do our best work when we are together.

For that reason, many roles are required to be performed on‑site.