Associate Director / Director, Clinical Project Delivery

Position Overview

The Associate Director / Director, Clinical Project Delivery provides hands-on operational leadership for the execution of one or more of Immunome’s clinical trials, facilitating all aspects of cross-functional clinical trial delivery from planning and initiation through completion—ensuring studies are executed on time, within budget, and in compliance with regulatory requirements and corporate objectives.  

This role acts as the primary point of accountability for study-level timelines, enrollment projections, budgets, and vendor performance for assigned trials, serving as a subject matter expert in clinical trial delivery and vendor oversight.    

The Associate Director / Director may be assigned to lead or support one or more development programs as well as functional or departmental initiatives.  

Responsibilities

Clinical Project Delivery   

• Own cross-functional facilitation of clinical study teams through the trial lifecycle.  

• Own study-level timeline development, tracking, and reporting for assigned trials.  

• Develop and maintain enrollment graphs and dashboards, ensuring accuracy and timely updates to inform decision-making.  

• Monitor project delivery metrics (timelines, milestones, enrollment, budget adherence, TMF and vendor KPIs) and drive corrective action when studies are at risk.  

• Lead cross-functional planning, execution, and delivery of assigned clinical trials on time, within budget, and to quality standards.   

• Identify operational risks and implement mitigation strategies to ensure successful trial delivery.  

Clinical Operations Leadership  

• Support resource planning and capability building to meet the demands of a rapidly expanding clinical portfolio.  

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

• May be assigned one or more direct reports with the expectation of providing coaching, mentorship, and development.  

• Guide and mentor new and junior Clinical Operations team members.  

Vendor Management  

• Own CROs and central lab vendor relationships and oversight for assigned studies.  

• Owns vendor identification, selection, contracting, and onboarding activities in partnership with Finance, Legal, and clinical study teams.  

• Manage and monitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.  

• Lead governance meetings, oversight activities, and drive issue escalation and resolution to ensure timely and effective trial execution.  

Quality Assurance and Regulatory Compliance  

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

• Partner with Quality Assurance and the Clinical Study Team to ensure ongoing inspection-readiness and implement corrective actions as needed.  

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

Cross-Functional Collaboration  

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

• Partner with Clinical Site & Trial Operations, Clinical Field Monitoring & Trial Operations, and Clinical Development Systems to align on trial delivery strategy and execution.  

• Partner with cross-functional teams to identify and mitigate study delivery risks.  

• Provide study-level operational input into program-level discussions and decisions.  

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

Budget and Resource Management   

• Partner with Finance to manage and forecast study-level budgets, including change orders ensuring alignment with corporate priorities and program timelines.  

• Maintain financial oversight for vendor and study-related activities, strictly tracking, managing, and escalating Change Orders and Change Notifications.  

• Track and report on budget adherence for assigned studies.  

Qualifications

• Bachelor’s degree with at least 8+ years (for AD), or 10+ years (for Director) of clinical project management experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.

• Demonstrated expertise directly managing clinical trial vendors, including CROs and central labs.  

• Demonstrated experience in study timeline development, enrollment forecasting, and tracking methodologies, and trial risk management.  

• Proven track record managing complex clinical trials in a pharmaceutical or biotech environment.  

Knowledge and Skills

• Deep understanding of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, and EMA).  

• Strong, hands-on experience managing CROs and other vendors across the full trial lifecycle.  

• Strong project management skills; PMP Certification preferred.  

• Ability to effectively work cross-functionally and influence stakeholders without direct authority.  

• Excellent communication, negotiation, and interpersonal skills.  

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

• Ability to prioritize and manage multiple complex projects and vendors simultaneously in a fast-paced, dynamic environment.  

• Highly professional, adaptable, and accountable.