Director, Clinical Trial Operations & Strategy

Regeneron Pharmaceuticals, Inc.; Armonk, Cambridge (NY, MA); Hybrid; AUD 302,000 - 504,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director Clinical Trial Management Program Operations Leader to drive operational strategy for complex clinical programs within a hybrid U.S. work setup.

You will collaborate with senior leaders, vendors, and study teams to ensure timely, within-budget delivery. The role requires extensive experience in clinical operations, budgeting, scheduling, and resource management, with a focus on oversight of CROs and external partners and ensuring inspection

Qualifications

• Bachelor's degree mandatory; advanced degree may substitute for experience.
• Minimum 12 years of relevant proven experience, with at least 8 years in clinical operations.
• Knowledge of ICH/GCP, SOPs and regulatory requirements.
• Experience leading CROs, vendors and external partners.
• Ability to communicate effectively with senior management and cross-functional teams.

Responsibilities

• Lead operational strategy and delivery for complex clinical programs.
• Oversee program quality, timelines, budgets, and study team success.
• Provide input to CST concepts, feasibility, timelines and cost estimates.
• Review plans during protocol design, startup and conduct.
• Drive decisions, monitor KPIs and implement risk mitigation.
• Lead vendor selection, CRO oversight, governance activities and partner meetings.
• Ensure inspection readiness and support for Regulatory Authority inspections.

Skills

Program leadership

Executive communication

Staff leadership

Resource forecasting

Budget & timelines management

Regulatory oversight

Vendor management

Governance & committees

Education

Bachelor's degree

Advanced degree (e.g., PhD/MD) may substitute for experience

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Director Clinical Trial Management Program Operations Leader to drive operational strategy for complex clinical programs within a hybrid U.S. work setup.

You will collaborate with senior leaders, vendors, and study teams to ensure timely, within-budget delivery. The role requires extensive experience in clinical operations, budgeting, scheduling, and resource management, with a focus on oversight of CROs and external partners and ensuring inspection