Director Program Operations Leader

Buildourfuturetogether:

AtRegeneron,we use science and innovation todevelop life-changing medicines for people with serious diseases. We are seeking a DirectorClinicalTrialManagement Program Operations Leader to join ourClinicalTrialManagement team, supporting our clinical development organization in a hybrid work mode. In this role, you willleadoperationalstrategyanddeliveryforcomplexclinicalprograms while collaborating with senior leaders, vendors, collaboration partners, and clinical study teams. This position offers the opportunity tocontribute to a fast-growing,science-driven organization makingameaningfuldifference to patients worldwide.

When&where:

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

Discoveryourrole:

• Leadoperationalstrategyand overalldeliveryforcomplexclinicalprograms.

• Oversee program quality, timelines, budgets, and study team success.

• Provide operational input to Clinical Study Concepts, feasibility, timelines, and cost estimates.

• Review plans during protocoldesign, study startup, and study conduct.

• Drive decisions,monitorKPIs, 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 bringaninnovativeapproach to solving operational challenges and advancing guidelines.

• Bachelor’sdegree.

• Advanceddegree may be considered in lieu ofprovenexperience.

• Minimum 12 years of relevantprovenexperience.

• Minimum8yearsofexperience within clinical operations.

• Knowledge of applicable regulations, International Council forHarmonisation/Good Clinical Practice (ICH/GCP), and SOPs.

• Experience leadingcomplexclinicalprograms and handling operational strategy, budgets, timelines, and resources.

• Experience forecasting and allocatingClinicalTrialManagement resources across programs.

• Experiencemanaging Clinical Research Organizations (CROs), vendors, and external partners.

• Experience representingClinicalTrialManagement at review committees and governance meetings.

• Experience leading staff recruitment, performance management, development, coaching,mentoring, training, and compliance activities.

• Abilitytocommunicate 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 visithttps://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)