Director, Clinical Site and Trial Operations

Responsibilities

• Lead site management and trial operations across the oncology portfolio from planning through completion
• Review protocols, clinical plans, and trial documentation for feasibility and alignment with objectives
• Identify and mitigate operational risks to ensure successful trial delivery
• Build, lead, and mentor a high-performing CSTO team
• Establish strategic vision and implement operational best practices and SOPs
• Oversee day-to-day management of vendors including CROs and central labs
• Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements
• Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions
• Manage and forecast clinical trial budgets and resource allocation

Requirements

• Bachelor’s degree with 12+ years of clinical operations experience in biotech or pharma
• Master’s degree with 10+ years of experience
• Ph.D. with 8+ years managing clinical operations in oncology or related therapeutic areas
• Deep understanding of clinical development processes and trial design
• Expertise in ICH-GCP, FDA, and EMA regulations
• Proven ability to lead global clinical trials across phases I–III
• Strong project management and cross-functional leadership skills

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.