Position OverviewThe Director, Clinical Site and Trial Operations (CSTO) provides strategic and operational leadership for Immunome's clinical trials, overseeing all aspects of site-facing trial execution-from planning and initiation through site and trail closeout-ensuring studies are conducted in compliance with regulatory requirements and corporate objectives.
The Director will lead and develop a high-performing CSTO team, partner closely with Clinical Project Delivery on trial delivery, oversee day-to-day vendor management, and establish site-facing best practices to ensure operational excellence. The Director will collaborate with cross-functional stakeholders, including Clinical Development, Regulatory Affairs, Medical Affairs, CMC, and Quality, to ensure the successful execution of Immunome's clinical trials.
The Director may also lead one or more outsourced trials and/or lead US site management and trial operations activities on mixed model studies where US site management and monitoring is conducted in-house, and ex-US is outsourced.
ResponsibilitiesClinical Trial Oversight - Lead site management and trial operations across Immunome's oncology portfolio from planning through completion, ensuring studies meet timelines, budgets, and quality standards.
- Review protocols, clinical plans, and trial documentation for feasibility and alignment with company and trial objectives.
- Identify and mitigate operational risks to ensure successful trial delivery.
Clinical Operations Leadership - Build, lead, and mentor a high-performing CSTO team.
- Establish a strategic vision for the function and implement operational best practices and SOPs in collaboration with cross-functional teams.
- Support long-term resource planning and department growth for a rapidly expanding clinical portfolio.
- Champion a culture of accountability, collaboration, and continuous improvement.
Vendor and CRO Management - Oversee day-to-day management of vendors including CROs and central labs.
- Ensure vendor compliance with contractual obligations, timelines, and performance metrics for site management.
- Contribute to governance, vendor oversight, and quality management and improvement processes for effective trial execution.
Quality Assurance and Regulatory Compliance - Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements.
- Partner with Quality Assurance on inspection readiness and 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.
- Represent CSTO in l governance meetings and provide operational input into strategic decisions.
- Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed.
Budget and Resource Management - Support Project Delivery in developing, managing, and forecasting Clinical trial budgets, aligned with corporate priorities and program timelines.
- Oversee CTSO resource allocation to optimize team performance and deliver milestones on time.
- Maintain financial oversight of site budgets and site management and monitoring activities, whether conducted by in-house teams or outsourced.
Qualifications- Bachelor's degree with 12+ years of clinical operations experience within the biotechnology or pharmaceutical industry; Master's degree with 10+ years; or Ph.D. with 8+ years managing clinical operations in oncology or related therapeutic area; or equivalent experience.
Knowledge and Skills- Deep understanding of clinical development processes, trial design, and global regulatory frameworks.
- Ability to lead global clinical trials across multiple development phases (I-III).
- Expertise in ICH-GCP, FDA, and EMA regulations.
- Strong operational acumen and project management skills.
- Proven ability to lead cross-functional initiatives and influence stakeholders at all organizational levels.
- Ability to build, lead, and mentor high-performing CSTO teams.
- Exceptional communication, negotiation, and interpersonal skills.
- Analytical mindset with a strategic approach to problem-solving and decision-making.
- Ability to manage multiple complex projects in a dynamic environment.
- High degree of professionalism, adaptability, and accountability.
Washington State Pay Range
$225,442-$254,130 USD
