Director, Clinical Trial Operations & Strategy

Regeneron; Armonk (NY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) match

Health insurance

Paid time off

Family benefits

Job summary

Regeneron in the United States is seeking a Director Clinical Trial Management Program Operations Leader to guide operational strategy for complex clinical programs. The role works with senior leaders, vendors, partners, and study teams in a hybrid model.

You will oversee budgets, timelines, feasibility input, protocol reviews, KPI monitoring, risk mitigation, and regulatory inspection readiness. A Bachelor's degree and 12+ years in clinical operations are required, advanced degrees considered.

Qualifications

• Bachelor's degree required.
• 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 ICH/GCP and SOPs.
• Experience leading complex clinical programs and handling budgets, timelines, and resources.
• Experience managing CROs, vendors, and external partners.
• Experience representing Clinical Trial Management at governance meetings.

Responsibilities

• Lead operational strategy and overall delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide operational input to 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 cross-functional support for regulatory inspections.

Skills

Operational leadership

Budget management

Program delivery

Cross-functional leadership

ICH/GCP knowledge

Vendor management

Staff development

Senior stakeholder comms

Education

Bachelor's degree

Advanced degree

Job description

Regeneron in the United States is seeking a Director Clinical Trial Management Program Operations Leader to guide operational strategy for complex clinical programs. The role works with senior leaders, vendors, partners, and study teams in a hybrid model.

You will oversee budgets, timelines, feasibility input, protocol reviews, KPI monitoring, risk mitigation, and regulatory inspection readiness. A Bachelor's degree and 12+ years in clinical operations are required, advanced degrees considered.