Senior Manager, Clinical Project Management (Project Delivery)

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. #J-18808-Ljbffr Immunome, Inc.