Full Job Description
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!
Salary Range (annually)
$205,000.00 - $341,600.00
