Senior Manager, Clinical Project Management (Project Delivery)

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 Senior Manager, Clinical Project Management (Clinical Project Delivery CPD) provides hands-on operational management for the execution of one or more of Immunome’s clinical trials, supporting all aspects of cross-functional clinical trial delivery from planning and initiation through completion to ensure studies are executed on time, within budget, and in compliance with regulatory requirements and corporate objectives.
• The Senior Manager acts as the primary point of accountability for study-level timelines, enrollment projections, budgets, and vendor performance for assigned trials.
• The Senior Manager may support one or more studies and/or development programs under the guidance of an Associate Director or above.

Responsibilities

Clinical Project Delivery

• Lead 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, vendor KPIs) and ensure corrective action when studies are at risk.
• Facilitate or support cross-functional planning, execution, and delivery of assigned clinical trials on time, within budget, and to quality standards.
• Help the clinical study team (CST) identify operational risks and implement mitigation strategies to ensure successful trial delivery.

Clinical Operations

• Champion a culture of accountability, collaboration, and continuous improvement.
• May contribute to functional and/or departmental initiatives.
• May mentor new or junior team members.

Vendor Management

• Manage CRO and Central lab relationships and oversight for assigned studies.
• Initiate vendor identification, selection, contracting, and onboarding activities in support of Finance, Legal, and clinical study teams.
• Manage and monitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
• Support vendor governance meetings, oversight activities, 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.
• Work with Quality Assurance and the CST to support and ensure ongoing inspection- readiness and implement corrective actions as needed.
• Help ensure data integrity and consistent trial conduct across assigned trials.

Cross-Functional Collaboration

• Align cross-functionally on program objectives and study execution plans, including Clinical Site & Trial Operations, Clinical Field Monitoring & Trial Operations, and Clinical Development Systems.
• Work 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

• Work with Finance to support management and forecasting of study-level budgets, including change orders, ensuring alignment with corporate priorities and program timelines.
• Maintain financial oversight for vendor and study-related activities with strict oversight of Change Orders and Change Notifications.
• Track and report on budget adherence for assigned studies.

Qualifications

• Bachelor’s degree plus a minimum of 6 years of clinical project management or clinical trial experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.
• A minimum of 3 years of sponsor experience.
• Demonstrated experience managing or supporting clinical trial vendors, including CROs and central labs.
• Working knowledge and experience in study timeline development, enrollment forecasting and tracking methodologies, and trial risk management.
• Experience managing or supporting complex clinical trials in a pharmaceutical or biotech environment.
• Demonstrated experience supporting or managing Trial Master Files.

Knowledge and Skills

• Strong working knowledge of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, and EMA).
• Experience managing CROs and other vendors across the trial lifecycle.
• Solid project management skills; PMP Certification a plus.
• Ability to effectively work cross-functionally and build relationships with stakeholders without direct authority.
• Strong and effective communication, negotiation, and interpersonal skills.
• Detail-oriented with an analytical approach to problem-solving.
• Ability to prioritize and manage multiple tasks and projects in a fast-paced, dynamic environment.
• Highly professional, adaptable, and accountable.

Washington State Pay Range

$175,000—$199,577 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.

E-Verify

Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).