Associate Director / Director, Clinical Project Delivery

Associate Director / Director, Clinical Project Delivery

Bothell, Washington, United States

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

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.
• 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.
• 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.

Washington State Pay Range

$186,426 - $211,713 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.