Position OverviewThe Associate Director / Director, Clinical Project Delivery provides hands-on operational leadership for the execution of one or more of Immunome's clinical trials, facilitating all aspects of cross-functional 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.
This role acts as the primary point of accountability for study-level timelines, enrollment projections, budgets, and vendor performance for assigned trials, serving as a subject matter expert in clinical trial delivery and vendor oversight.
The Associate Director / Director may be assigned to lead or support one or more development programs as well as functional or departmental initiatives.
ResponsibilitiesClinical Project Delivery - Own 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, TMF and vendor KPIs) and drive corrective action when studies are at risk.
- Lead cross-functional planning, execution, and delivery of assigned clinical trials on time, within budget, and to quality standards.
- Identify operational risks and implement mitigation strategies to ensure successful trial delivery.
Clinical Operations Leadership - Support resource planning and capability building to meet the demands of a rapidly expanding clinical portfolio.
- Champion a culture of accountability, collaboration, and continuous improvement.
- May be assigned one or more direct reports with the expectation of providing coaching, mentorship, and development.
- Guide and mentor new and junior Clinical Operations team members.
Vendor Management - Own CROs and central lab vendor relationships and oversight for assigned studies.
- Owns vendor identification, selection, contracting, and onboarding activities in partnership with Finance, Legal, and clinical study teams.
- Manage and monitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
- Lead governance meetings, oversight activities, and drive 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.
- Partner with Quality Assurance and the Clinical Study Team to ensure ongoing inspection-readiness and implement corrective actions as needed.
- Drive operational excellence to ensure data integrity and consistent trial conduct across assigned trials.
Cross-Functional Collaboration - Align cross-functionally on program objectives and study execution plans.
- Partner with Clinical Site & Trial Operations, Clinical Field Monitoring & Trial Operations, and Clinical Development Systems to align on trial delivery strategy and execution.
- Partner 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 - Partner with Finance to manage and forecast study-level budgets, including change orders ensuring alignment with corporate priorities and program timelines.
- Maintain financial oversight for vendor and study-related activities, strictly tracking, managing, and escalating Change Orders and Change Notifications.
- Track and report on budget adherence for assigned studies.
Qualifications- Bachelor's degree with at least 8+ years (for AD), or 10+ years (for Director) of clinical project management experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.
- Demonstrated expertise directly managing clinical trial vendors, including CROs and central labs.
- Demonstrated experience in study timeline development, enrollment forecasting, and tracking methodologies, and trial risk management.
- Proven track record managing complex clinical trials 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).
- Strong, hands-on experience managing CROs and other vendors across the full trial lifecycle.
- Strong project management skills; PMP Certification preferred.
- Ability to effectively work cross-functionally and influence stakeholders without direct authority.
- Excellent communication, negotiation, and interpersonal skills.
- Analytical mindset with a strategic approach to problem-solving and decision-making.
- Ability to prioritize and manage multiple complex projects and vendors simultaneously in a fast-paced, dynamic environment.
- Highly professional, adaptable, and accountable.
Washington State Pay Range
$186,426-$211,713 USD
