Clinical Trial Operations Director: Strategy & Delivery Leader

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

Benefits offered by this job

Hybrid work model

Job summary

Regeneron Pharmaceuticals, a leader in biotech, seeks a Director to manage Clinical Trial Management Program Operations in a hybrid US-based role. You will orchestrate complex programs, coordinate senior stakeholders, and drive budgets, timelines, and vendor partnerships to ensure study success.

Responsibilities include leading cross-functional study teams, forecasting resources, and supporting regulatory readiness.

Qualifications

• Bachelor’s degree required; advanced degree may be considered in lieu of experience.
• Minimum 12 years in clinical operations or related fields.
• Knowledge of ICH/GCP and SOPs.

Responsibilities

• Lead operational strategy and delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide input on feasibility, timelines, and cost estimates.
• Review plans during protocol design, startup, and conduct.
• Manage vendor selection, CRO oversight, and governance meetings.
• Ensure inspection readiness and support for regulatory inspections.

Skills

Strategic leadership

Program delivery

Budget management

Vendor management

CRO oversight

Regulatory inspection readiness

Staff recruitment and coaching

Communication with senior management

Education

Bachelor’s degree

Advanced degree preferred

Job description

Regeneron Pharmaceuticals, a leader in biotech, seeks a Director to manage Clinical Trial Management Program Operations in a hybrid US-based role. You will orchestrate complex programs, coordinate senior stakeholders, and drive budgets, timelines, and vendor partnerships to ensure study success.

Responsibilities include leading cross-functional study teams, forecasting resources, and supporting regulatory readiness.