Senior Director, U.S. Regional Clinical Operations (Biotech)

TL;DR

Senior Director, U.S. Regional Clinical Operations (Clinical Operations): Leading the U.S. clinical operational trial execution and delivery of the IND portfolio with an accent on site activation, monitoring oversight, and strategic site partnerships. Focus on building a high-performing clinical operations organization and optimizing enrollment performance across oncology and cell therapy programs.

Location: Hybrid; Must be based in or be able to work from Somerset, NJ, and be authorized to work in the United States

Salary: $222,672 - $292,258 USD

Company

Global biotechnology company dedicated to developing advanced cell therapies to treat and cure life-threatening diseases.

What you will do

• Lead and develop the U.S. Regional Clinical Operations organization, including site management and startup personnel.
• Oversee U.S. study startup activities, site selection, and enrollment readiness to accelerate timelines.
• Manage regional site monitoring and ensure continuous inspection readiness in accordance with FDA and ICH-GCP.
• Execute U.S. site engagement strategies to strengthen partnerships with research institutions, KOLs, and site networks.
• Manage departmental budgets, resource forecasting, and workforce planning for the U.S. portfolio.
• Represent regional operational strategy within global clinical development teams and governance forums.

Requirements

• Bachelor’s degree in a scientific or health care discipline (Advanced degree preferred).
• Minimum 15+ years of clinical operations experience within biotech, pharma, or CRO organizations.
• Minimum 8+ years of people leadership experience.
• Proven delivery of ambitious site start-up cycle times and enrollment execution in the U.S.
• Experience overseeing complex Phase I–IV global clinical trials, preferably in oncology or cell therapy.
• Expert knowledge of FDA regulations, ICH-GCP, and risk-based quality management.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation, personal, sick time, and eleven company holidays.
• Flexible spending and health savings accounts (FSA/HSA).
• Additional voluntary benefits including legal assistance, life insurance, and pet insurance.