Director Program Operations Leader

Regeneron Pharmaceuticals; Town of Cambridge; Hybrid; AUD 295,000 - 492,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Director Clinical Trial Management Program Operations Leader to guide operational strategy and delivery for complex clinical programs within a hybrid US-based setting. You will oversee quality, timelines, budgets, and study teams while coordinating with senior leaders, CROs, and vendors to ensure inspection readiness.

The role requires a Bachelor’s degree (advanced degree preferred) and 12+ years of clinical experience, including 8+ years in operations,

Qualifications

• Requires Bachelor's degree; advanced degree may be considered in lieu of experience.
• Minimum 12 years of relevant proven experience; 8+ years in clinical operations.

Responsibilities

• Lead operational strategy and delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide operational input to protocol design, feasibility, timelines, and cost estimates.
• Review plans during startup and conduct; drive decisions and monitor KPIs.

Skills

Operational leadership

Vendor management

CRO oversight

Regulatory readiness

Budget management

Staff leadership

Communication

Clinical operations

Forecasting resources

Education

Bachelor's degree in a related field

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. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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, and 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 educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $205,000.00 - $341,600.00 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.