Senior Director, Clinical Project Management
Immunome, Inc.Bothell, Washington, United States · Posted 14 days agoDescription
Company Overview
Position Overview
The Senior Director, Clinical Project Management 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 clinical project delivery (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
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