Senior Director, Clinical Trial Delivery

Immunomeinc; Bothell (WA); On-site; USD 261,000 - 309,000; Full time

Job summary

Immunome, Inc. is seeking a Senior Director of Clinical Project Delivery to lead the end-to-end management of the clinical trial portfolio.

The role focuses on delivering studies on time and within budget while maintaining regulatory compliance and corporate objectives. You will build and mentor a high-performing CPD team, oversee study timelines and enrollment forecasting, manage vendor relationships, and drive cross-functional governance across programs.

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.

Responsibilities

• Establish a strategic vision for the CPD function and 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Skills

Clinical project management

Team leadership

Study timelines

Enrollment forecasting

Trial risk management

Portfolio management

Education

Bachelor’s degree

Job description

Immunome, Inc. is seeking a Senior Director of Clinical Project Delivery to lead the end-to-end management of the clinical trial portfolio.

The role focuses on delivering studies on time and within budget while maintaining regulatory compliance and corporate objectives. You will build and mentor a high-performing CPD team, oversee study timelines and enrollment forecasting, manage vendor relationships, and drive cross-functional governance across programs.