Director Program Operations Leader at Regeneron in Cambridge, MA

Director Program Operations Leader
Location: Armonk
Buildourfuturetogether:
AtRegeneron,we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director ClinicalTrialManagement Program Operations Leader to join our ClinicalTrialManagement team, supporting our clinical development organization in a hybrid work mode. In this role, you will leadoperationalstrategyanddeliveryforcomplexclinicalprograms 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 ameaningfuldifference to patients worldwide.
When&where:
US - Armonk, Warren or Cambridge - Hybrid (3 days in the office)
Discoveryourrole:
Leadoperationalstrategyand overall deliveryforcomplexclinicalprograms.
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, 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 bring aninnovativeapproach to solving operational challenges and advancing guidelines.
Thisrolerequires:
Bachelor’sdegree.
Advanceddegree may be considered in lieu of provenexperience.
Minimum 12 years of relevant provenexperience.
Minimum8yearsofexperience within clinical operations.
Knowledge of applicable regulations, International Council for Harmonisation/Good Clinical Practice (ICH/GCP), and SOPs.
Experience leading complexclinicalprograms and handling operational strategy, budgets, timelines, and resources.
Experience forecasting and allocating ClinicalTrialManagement resources across programs.
Experience managing Clinical Research Organizations (CROs), vendors, and external partners.
Experience representing ClinicalTrialManagement 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 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
Additional Locations: Warren, Cambridge