Director, Clinical Site and Trial Operations

Position Overview

The Director, Clinical Site and Trial Operations (CSTO) provides strategic and operational leadership for Immunome’s clinical trials, overseeing all aspects of site-facing trial execution—from planning and initiation through site and trail closeout—ensuring studies are conducted in compliance with regulatory requirements and corporate objectives.

Responsibilities

• Lead site management and trial operations across Immunome’s oncology portfolio from planning through completion, ensuring studies meet timelines, budgets, and quality standards.

• Review protocols, clinical plans, and trial documentation for feasibility and alignment with company and trial objectives.

• Identify and mitigate operational risks to ensure successful trial delivery.

• Build, lead, and mentor a high-performing CSTO team.

• Establish a strategic vision for the function and implement operational best practices and SOPs in collaboration with cross-functional teams.

• Support long-term resource planning and department growth for a rapidly expanding clinical portfolio.

• Champion a culture of accountability, collaboration, and continuous improvement.

• Oversee day-to-day management of vendors including CROs and central labs.

• Ensure vendor compliance with contractual obligations, timelines, and performance metrics for site management.

• Contribute to governance, vendor oversight, and quality management and improvement processes for effective trial execution.

• Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements.

• Partner with Quality Assurance on inspection readiness and corrective actions as needed.

• Drive operational excellence to ensure data integrity and consistent trial conduct.

• Align cross-functionally on program objectives and execution plans.

• Represent CSTO in governance meetings and provide operational input into strategic decisions.

• Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed.

• Support Project Delivery in developing, managing, and forecasting Clinical trial budgets, aligned with corporate priorities and program timelines.

• Oversee CTSO resource allocation to optimize team performance and deliver milestones on time.

• Maintain financial oversight of site budgets and site management and monitoring activities, whether conducted by in-house teams or outsourced.

Qualifications

• Bachelor’s degree with 12+ years of clinical operations experience within the biotechnology or pharmaceutical industry; Master’s degree with 10+ years; or Ph.D. with 8+ years managing clinical operations in oncology or related therapeutic area; or equivalent experience.

• Deep understanding of clinical development processes, trial design, and global regulatory frameworks.

• Ability to lead global clinical trials across multiple development phases (I–III).

• Expertise in ICH-GCP, FDA, and EMA regulations.

• Strong operational acumen and project management skills.

• Proven ability to lead cross-functional initiatives and influence stakeholders at all organizational levels.

• Ability to build, lead, and mentor high-performing CSTO teams.

• Exceptional communication, negotiation, and interpersonal skills.

• Analytical mindset with a strategic approach to problem-solving and decision-making.

• Ability to manage multiple complex projects in a dynamic environment.

• High degree of professionalism, adaptability, and accountability.

Washington State Pay Range

$225,442 - $254,130 USD