Director Program Operations Leader

Regeneron; Armonk (NY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) match

Health insurance

Paid time off

Family benefits

Job summary

Regeneron in the United States is seeking a Director Clinical Trial Management Program Operations Leader to guide operational strategy for complex clinical programs. The role works with senior leaders, vendors, partners, and study teams in a hybrid model.

You will oversee budgets, timelines, feasibility input, protocol reviews, KPI monitoring, risk mitigation, and regulatory inspection readiness. A Bachelor's degree and 12+ years in clinical operations are required, advanced degrees considered.

Qualifications

• Bachelor's degree required.
• 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 ICH/GCP and SOPs.
• Experience leading complex clinical programs and handling budgets, timelines, and resources.
• Experience managing CROs, vendors, and external partners.
• Experience representing Clinical Trial Management at governance meetings.

Responsibilities

• Lead operational strategy and overall delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide operational input to 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 cross-functional support for regulatory inspections.

Skills

Operational leadership

Budget management

Program delivery

Cross-functional leadership

ICH/GCP knowledge

Vendor management

Staff development

Senior stakeholder comms

Education

Bachelor's degree

Advanced degree

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.

When & where:

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

Discover your role:

• 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.

You bring an innovative approach to solving operational challenges and advancing guidelines.

This role requires:

• 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.

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

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and edu