Senior Director, Clinical Project Delivery
Immunome, Inc.
August 14, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
The Senior Director, Clinical Project Delivery (CPD) provides strategic and operational leadership for the clinical trial portfolio, overseeing 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.
Responsibilities
- Establish a strategic vision for CPD and, in partnership with Clinical Site and Trial Operations, implement standards, tools, and governance to deliver studies 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 on timeline management, enrollment forecasting/tracking, risk identification, and trial delivery best practices.
- Establish onboarding curricula and ongoing capability-building for staff.
- Set performance expectations, conduct evaluations, and support career development and succession planning.
- Own the framework for study-level timelines development, tracking, and reporting across the portfolio.
- Oversee enrollment graphs/dashboards to ensure accurate, timely updates for decision-making.
- Monitor/manage project delivery metrics (timelines, milestones, enrollment, budget adherence, vendor KPIs) and drive corrective action.
- Identify operational risks and implement mitigation strategies.
- Support long-term resource planning and department growth; contribute to departmental strategy.
- Oversee relationships with CROs, central labs, and clinical service providers; ensure vendor compliance; drive governance meetings and quality management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality Assurance for inspection readiness and corrective actions; drive data integrity and consistent trial conduct.
- Align cross-functionally on program objectives/execution; represent Clinical Operations in governance forums; support regulatory submissions and health authority interactions.
- Partner with Finance on clinical trial budget forecasting/management; oversee resource allocation and maintain financial oversight for in-house or outsourced activities.
Qualifications
- Bachelor’s degree with 14+ years of clinical project management experience in biotechnology/pharmaceuticals (or equivalent).
- Demonstrated experience building, training, and leading clinical project delivery teams.
- Expertise in study timeline development, enrollment forecasting/tracking, and trial risk management.
- Proven track record managing complex, multi-study portfolios.
Knowledge and Skills
- Deep understanding of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, EMA).
- Ability to build and lead global trials across Phase I–IV.
- Strong project management; PMP certification preferred.
- Ability to lead cross-functional initiatives and influence stakeholders.
- Ability to build/scale CPD teams, including managing people leaders.
- Exceptional communication, negotiation, and interpersonal skills.
- Analytical, strategic problem-solving; ability to prioritize in a fast-paced environment.
- High professionalism, adaptability, and accountability.
The Senior Director, Clinical Project Delivery (CPD) provides strategic and operational leadership for the clinical trial portfolio, overseeing 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.
Responsibilities
- Establish a strategic vision for CPD and, in partnership with Clinical Site and Trial Operations, implement standards, tools, and governance to deliver studies 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 on timeline management, enrollment forecasting/tracking, risk identification, and trial delivery best practices.
- Establish onboarding curricula and ongoing capability-building for staff.
- Set performance expectations, conduct evaluations, and support career development and succession planning.
- Own the framework for study-level timelines development, tracking, and reporting across the portfolio.
- Oversee enrollment graphs/dashboards to ensure accurate, timely updates for decision-making.
- Monitor/manage project delivery metrics (timelines, milestones, enrollment, budget adherence, vendor KPIs) and drive corrective action.
- Identify operational risks and implement mitigation strategies.
- Support long-term resource planning and department growth; contribute to departmental strategy.
- Oversee relationships with CROs, central labs, and clinical service providers; ensure vendor compliance; drive governance meetings and quality management.
- Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements; partner with Quality Assurance for inspection readiness and corrective actions; drive data integrity and consistent trial conduct.
- Align cross-functionally on program objectives/execution; represent Clinical Operations in governance forums; support regulatory submissions and health authority interactions.
- Partner with Finance on clinical trial budget forecasting/management; oversee resource allocation and maintain financial oversight for in-house or outsourced activities.
Qualifications
- Bachelor’s degree with 14+ years of clinical project management experience in biotechnology/pharmaceuticals (or equivalent).
- Demonstrated experience building, training, and leading clinical project delivery teams.
- Expertise in study timeline development, enrollment forecasting/tracking, and trial risk management.
- Proven track record managing complex, multi-study portfolios.
Knowledge and Skills
- Deep understanding of clinical development, trial design, and global regulatory frameworks (ICH-GCP, FDA, EMA).
- Ability to build and lead global trials across Phase I–IV.
- Strong project management; PMP certification preferred.
- Ability to lead cross-functional initiatives and influence stakeholders.
- Ability to build/scale CPD teams, including managing people leaders.
- Exceptional communication, negotiation, and interpersonal skills.
- Analytical, strategic problem-solving; ability to prioritize in a fast-paced environment.
- High professionalism, adaptability, and accountability.