Senior Manager, Clinical Project Management (Project Delivery)

Immunome, Inc.; Bothell (WA); On-site; USD 175,000 - 200,000; Full time

Job summary

Immunome, Inc. in Bothell, Washington, is seeking a Senior Manager to lead Clinical Project Management (Project Delivery) for multiple trials, ensuring on-time, on-budget, and compliant execution.

The role owns study timelines, enrollment projections, budgets, and vendor performance, with cross-functional collaboration and possible mentorship of junior team members.

Qualifications

• Bachelor’s degree plus 6+ years in clinical project management or trial experience in biotech/pharma.
• Minimum 3 years of sponsor experience.
• Experience managing or supporting CROs and central labs.
• Understanding of study timelines, enrollment forecasting, and risk management.
• Experience with complex trials in pharma/biotech environments.

Responsibilities

• Lead cross-functional study teams through the trial lifecycle.
• Own study-level timelines, enrollment projections, and budgets.
• Monitor metrics and drive corrective actions when at-risk.
• Manage CROs and central labs; vendor oversight.
• Support regulatory submissions and cross-functional program input.

Skills

Clinical project management

Sponsor experience

Vendor management

Study timelines

Education

Bachelor’s degree

Job description

Senior Manager, Clinical Project Management (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 Senior Manager, ClinicalProject Management (ClinicalProject DeliveryCPD) provideshands-onoperationalmanagementfortheexecution ofone or moreofImmunome’s clinicaltrials,supportingall aspects ofcross-functionalclinical trial deliveryfrom planning and initiation throughcompletiontoensurestudies areexecutedon time, within budget,and in compliance with regulatory requirements and corporate objectives.

TheSenior Manageractsas the primary point of accountability forstudy-level timelines,enrollment projections,budgets, and vendor performancefor assigned trials.

TheSenior Managermaysupportone or morestudiesand/or development programsunder 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 timel y updates to inform decision-making .
• Monitor project delivery metrics ( timelines, milestones , enrollment, budget adherence, vendor KPIs) and ensure correcti ve action when studies are at risk.
• Facilitate or support cross-functional planning, execution, and delivery of assigned clinical trials on time, w ith in budget, and to quality standards.
• Help the clinical study team (CST) i dentify 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.
• 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.
• M anage and m onitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
• S upport 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 - r eadiness 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 Developm ent Systems .
• Work with cross-functional teams to identify and mitigate study delivery risks.
• Provide study-level operational input into program-level discussions an d 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 manage ment and forecast ing 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 tr ia l 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 File s .

Knowledge and Skills

• Strong w orking knowledge of clinical development, trial design, and global regulatory frameworks ( ICH-GCP, FDA, and EMA ) .
• E xperience managing CROs and other vendors across the trial lifecycle.
• A bility to effectively work cross-functionally and build relationships with stakeholders without direct authority.
• Strong and effective communication, negotiation, and interpersonal skills.
• Detail- oriented with a n analytical approach to problem-solving .
• Ability to prioritize an d manage multiple tasks and projects in a fast- paced , dynamic environment.
• High ly professiona l , adaptab le , and accountab le .

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.