Director, Clinical Site and Trial Operations
Immunome, Inc.
July 01, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
- Director, Clinical Site and Trial Operations (CSTO) provides strategic and operational leadership for clinical trials, overseeing site-facing execution from planning/initiation through site/trial closeout to ensure compliance with regulatory requirements and corporate objectives.
- Leads and develops a CSTO team; partners with Clinical Project Delivery; oversees day-to-day vendor management; establishes site-facing best practices; collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, CMC, and Quality.
- May lead outsourced trials and/or in-house US site management/monitoring on mixed-model studies.
Responsibilities
- Lead site management and trial operations across the oncology portfolio from planning through completion, meeting timelines, budgets, and quality standards.
- Review protocols, clinical plans, and trial documentation for feasibility and alignment with company/trial objectives.
- Identify and mitigate operational risks for successful trial delivery.
- Build, lead, and mentor a high-performing CSTO team.
- Establish operational best practices and SOPs; support long-term resource planning.
- Oversee vendors (CROs, central labs), ensuring contractual compliance, timelines, and performance metrics.
- Ensure adherence to ICH-GCP and global regulatory requirements; partner with Quality on inspection readiness and corrective actions.
- Drive data integrity and consistent trial conduct.
- Align cross-functionally on program objectives; represent CSTO in governance; support IND/NDA/BLA submissions and health authority interactions.
- Support trial budget development/forecasting; oversee CTSO resource allocation; maintain financial oversight of site budgets and monitoring (in-house or outsourced).
Qualifications
- Bachelor’s degree with 12+ years (biotech/pharma clinical operations); or Master’s degree with 10+ years; or Ph.D. with 8+ years; or equivalent experience.
Knowledge and Skills
- Deep understanding of clinical development, trial design, and global regulatory frameworks.
- Ability to lead global clinical trials across phases I–III.
- Expertise in ICH-GCP, FDA, and EMA regulations.
- Strong operational/project management skills; proven cross-functional leadership and stakeholder influence.
- Ability to build/mentor CSTO teams; exceptional communication/negotiation/interpersonal skills.
- Analytical, strategic problem-solving; ability to manage multiple complex projects; professionalism, adaptability, accountability.
- Director, Clinical Site and Trial Operations (CSTO) provides strategic and operational leadership for clinical trials, overseeing site-facing execution from planning/initiation through site/trial closeout to ensure compliance with regulatory requirements and corporate objectives.
- Leads and develops a CSTO team; partners with Clinical Project Delivery; oversees day-to-day vendor management; establishes site-facing best practices; collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, CMC, and Quality.
- May lead outsourced trials and/or in-house US site management/monitoring on mixed-model studies.
Responsibilities
- Lead site management and trial operations across the oncology portfolio from planning through completion, meeting timelines, budgets, and quality standards.
- Review protocols, clinical plans, and trial documentation for feasibility and alignment with company/trial objectives.
- Identify and mitigate operational risks for successful trial delivery.
- Build, lead, and mentor a high-performing CSTO team.
- Establish operational best practices and SOPs; support long-term resource planning.
- Oversee vendors (CROs, central labs), ensuring contractual compliance, timelines, and performance metrics.
- Ensure adherence to ICH-GCP and global regulatory requirements; partner with Quality on inspection readiness and corrective actions.
- Drive data integrity and consistent trial conduct.
- Align cross-functionally on program objectives; represent CSTO in governance; support IND/NDA/BLA submissions and health authority interactions.
- Support trial budget development/forecasting; oversee CTSO resource allocation; maintain financial oversight of site budgets and monitoring (in-house or outsourced).
Qualifications
- Bachelor’s degree with 12+ years (biotech/pharma clinical operations); or Master’s degree with 10+ years; or Ph.D. with 8+ years; or equivalent experience.
Knowledge and Skills
- Deep understanding of clinical development, trial design, and global regulatory frameworks.
- Ability to lead global clinical trials across phases I–III.
- Expertise in ICH-GCP, FDA, and EMA regulations.
- Strong operational/project management skills; proven cross-functional leadership and stakeholder influence.
- Ability to build/mentor CSTO teams; exceptional communication/negotiation/interpersonal skills.
- Analytical, strategic problem-solving; ability to manage multiple complex projects; professionalism, adaptability, accountability.