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.