Director, Clinical Trial Ops & Program Strategy

BioSpace; Armonk (NY); Hybrid; USD 205,000 - 342,000; Full time

Job summary

Regeneron is seeking a Director of Clinical Trial Management Program Operations Leader to guide operational strategy and delivery for complex clinical programs. You will oversee timelines, budgets, study team success, and vendor partnerships in a hybrid US work model with onsite days in Armonk, Warren, or Cambridge.

The role requires 12+ years in clinical operations, strong ICH/GCP knowledge, and proven leadership in cross-functional programs, forecasting resources, and regulatory readiness.

Qualifications

• Minimum 12 years of relevant proven experience.
• Minimum 8 years of experience within clinical operations.
• Knowledge of 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 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.

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

CRO oversight

Vendor management

Program management

Budget management

KPI monitoring

Risk mitigation

Regulatory inspections

Staff development

Education

Bachelor's degree

Advanced degree preferred

Job description

Regeneron is seeking a Director of Clinical Trial Management Program Operations Leader to guide operational strategy and delivery for complex clinical programs. You will oversee timelines, budgets, study team success, and vendor partnerships in a hybrid US work model with onsite days in Armonk, Warren, or Cambridge.

The role requires 12+ years in clinical operations, strong ICH/GCP knowledge, and proven leadership in cross-functional programs, forecasting resources, and regulatory readiness.