Director, Clinical Trial Programs & Operations

Regeneron Pharmaceuticals, Inc; Armonk (NY); Hybrid; USD 205,000 - 342,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Armonk, NY, is seeking a Director Clinical Trial Management Program Operations Leader.

You will lead operational strategy for complex clinical programs, oversee budgets and study teams, and drive regulatory readiness in a hybrid work environment. The role requires 12+ years in clinical operations, strong vendor/CRO management, and solid communication with senior leadership.

Qualifications

• Bachelor's degree required; advanced degree may replace experience.
• Minimum 12 years of relevant proven experience.
• Minimum 8 years in clinical operations.
• Knowledge of ICH/GCP and SOPs.
• Experience leading complex clinical programs and managing budgets, timelines and resources.
• Experience forecasting and allocating CTM resources across programs.
• Experience managing CROs, vendors and external partners.
• Experience presenting CTM at governance meetings.
• Experience leading staff recruitment, performance management and development.
• Ability to communicate with senior management and cross-functional teams.

Responsibilities

• 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.
• Bring innovative approaches to solving operational challenges and advancing guidelines.

Skills

Operational strategy

Budget management

Vendor management

CRO oversight

Regulatory collaboration

Staff recruitment and development

Cross-functional leadership

Program governance

Communication with senior management

Education

Bachelor's degree

Advanced degree (optional)

Job description

Regeneron Pharmaceuticals, Inc. in Armonk, NY, is seeking a Director Clinical Trial Management Program Operations Leader.

You will lead operational strategy for complex clinical programs, oversee budgets and study teams, and drive regulatory readiness in a hybrid work environment. The role requires 12+ years in clinical operations, strong vendor/CRO management, and solid communication with senior leadership.