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 Director, Clinical Project Delivery (CPD) provides strategic and operational leadership for Immunome’s clinical trial portfolio, overseeing all aspects of clinical trial delivery from planning and initiation through completion—ensuring studies are executed on time, within budget, and in compliance with regulatory requirements and corporate objectives.
The person in this role will build a high-performing CPD team responsible for managing overall project delivery of Immunome’s clinical trials, serving as both people leader and subject matter expert to drive consistency and operational excellence in how project delivery is executed across programs.
The Senior Director may also be assigned to oversee one or more development programs and/or lead key projects.
Responsibilities
Clinical Project Delivery Team Leadership and Development
- Establish a strategic vision for the CPD function and in partnership with Clinical Site and Trial Operations implement standards, tools, and governance needed to ensure studies are delivered on time, within scope and to quality expectations.
- Build, lead, and mentor a team of project delivery leads / project management leads.
- Design and deliver training programs on timeline management, enrollment forecasting/tracking, risk identification and trial delivery best practices.
- Establish onboarding curricula and ongoing capability-building for new and existing staff.
- Set performance expectations, conduct evaluations, and support career development and succession planning within the team.
Project and Portfolio Delivery Oversight
- Own the overall framework for study-level timelines development, tracking, and reporting across the portfolio.
- Oversee development and maintenance of enrollment graphs and dashboards, ensuring accuracy and timely updates to inform decision-making.
- Monitor and manage project delivery metrics (timelines, milestones, enrollment, budget adherence, vendor KPIs) and drive corrective action when studies are at risk.
- Oversee CPD team performance across trials.
- Identify operational risks and implement mitigation strategies to ensure successful trial delivery.
Clinical Operations Leadership
- Support long-term resource planning and department growth to meet the demands of a rapidly expanding clinical portfolio.
- Champion a culture of accountability, collaboration, and continuous improvement.
- Contribute to departmental strategy.
Vendor and CRO Management
- Oversee relationships with external partners including CROs, central labs, and clinical service providers.
- Ensure vendor compliance with contractual obligations, operational timelines, and performance metrics across the portfolio.
- Drive governance meetings, vendor oversight, and quality management processes to ensure effective trial execution.
Quality Assurance and Regulatory Compliance
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for clinical research.
- Partner with Quality Assurance to ensure ongoing inspection readiness and implement corrective actions as needed.
- Drive operational excellence to ensure data integrity and consistent trial conduct.
Cross-Functional Collaboration
- Align cross-functionally on program objectives and execution plans.
- Partner as needed to mitigate delivery risks.
- Represent Clinical Operations in governance forums and provide operational input into program and portfolio-level strategic decisions.
- Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed.
Budget and Resource Management
- Partner with Finance to oversee development, management, and forecasting of clinical trial budgets, ensuring alignment with corporate priorities and program timelines.
- Oversee resource allocation to optimize team performance and ensure timely delivery of all operational milestones.
- Maintain financial oversight for clinical trial activities, whether conducted by in-house teams or outsourced.
Qualifications
- Bachelor’s degree with 14+ years of clinical project management experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.
- Demonstrated experience building, training, and leading project delivery/clinical project management teams.
- Demonstrated expertise in study timeline development, enrollment forecasting and tracking methodologies, and trial risk management.
- Proven track record managing complex, multi-study portfolios in a pharmaceutical or biotech environment.
Knowledge and Skills
- Deep understanding of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, and EMA).
- Ability to build and lead global clinical trials across the full development lifecycle (Phase I–IV).
- Strong project management skills; PMP Certification preferred.
- Demonstrated ability to lead cross-functional initiatives and influence stakeholders at all organizational levels.
- Ability to build, lead, and scale high-performing CPD teams, including managing and developing people leaders.
- Exceptional communication, negotiation, and interpersonal skills.
- Analytical mindset with a strategic approach to problem-solving and decision-making.
- Ability to prioritize and manage multiple competing priorities in a fast-paced, dynamic environment.
- High degree of professionalism, adaptability, and accountability.
Washington State Pay Range
$260,965—$309,341 USD
