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.
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).