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 Manager, Clinical Project Delivery provides hands-on operational support for the execution of one or more of Immunome’s clinical trials, supporting cross-functional clinical trial delivery from planning and initiation through completion—to help ensure studies are executed on time, within budget, and in compliance with regulatory requirements and corporate objectives.
This role contributes to study-level timeline management, helps maintain enrollment projections, supports budget management and vendor performance oversight for assigned trials.
The Manager, Clinical Project Delivery may support one or more studies under the guidance of an Associate Director or above.
Responsibilities
Clinical Project Delivery
- Support cross-functional facilitation of clinical study teams through the trial lifecycle.
- Assist with study-level timeline development, tracking, and reporting for assigned trials.
- Help develop and maintain enrollment graphs and dashboards, ensuring accuracy and timely updates to inform decision-making.
- Help monitor project delivery metrics (timelines, milestones, enrollment, budget adherence, vendor KPIs) and drive corrective action when studies are at risk.
- Support cross-functional planning, execution, and delivery of assigned clinical trials on time, within budget, and to quality standards.
- Help identify operational risks and implement mitigation strategies to ensure successful trial delivery.
- Champion a culture of accountability, collaboration, and continuous improvement.
Vendor Management
- Support CRO and Central lab vendor relationships and oversight for assigned studies.
- Assist with vendor identification, selection, contracting, and onboarding activities in support of Finance, Legal, and clinical study teams.
- Help monitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
- May support governance meetings, oversight activities, issue escalation, and resolution to ensure timely and effective trial execution.
Quality Assurance and Regulatory Compliance
- Help ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for assigned trials.
- May work with Quality Assurance and the Clinical Study Team to ensure ongoing inspection-readiness and implement corrective actions as needed.
- Support data integrity and consistent trial conduct across assigned trials.
Cross-Functional Collaboration
- Participate in cross-functional alignment of program objectives and study execution plans.
- Support cross-functional teams to help identify and mitigate study delivery risks.
Budget and Resource Management
- Work with CPD and Finance to support management and forecasting of study-level budgets, including change orders, ensuring alignment with corporate priorities and program timelines as assigned.
- Assist with financial oversight for vendor and study-related activities.
- Help track and report on budget adherence for assigned studies.
Qualifications
- Bachelor’s degree with at least 4+ years of clinical project management and/or clinical trial experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.
- Demonstrated experience supporting clinical trial vendors, including CROs and central labs.
- Working knowledge of study timeline development, enrollment forecasting and tracking methodologies, and trial risk management.
- Demonstrated experience supporting management of Trial Master Files.
- Working knowledge of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, and EMA).
- Experience supporting CROs and other vendors across the trial lifecycle.
- Working knowledge of project management practices; PMP Certification a plus.
Knowledge and Skills
- Ability to effectively work cross-functionally and build relationships with stakeholders without direct authority.
- 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.
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).