Medical Director / Senior Medical Director, Clinical Development
Immunome, Inc.
June 30, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities
- Serve as the primary Medical Monitor for global clinical studies.
- Provide ongoing medical review of safety, efficacy, and eligibility data.
- Evaluate SAEs, AESIs, and emerging safety signals.
- Collaborate with Pharmacovigilance to ensure timely safety assessment, signal detection, and risk management.
- Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.
- Ensure subject safety remains the primary consideration in study conduct and decision-making.
- Provide medical oversight of study execution from initiation through database lock and study reporting.
- Support protocol development and amendments, informed consent forms, and study-related documents.
- Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant study issues.
- Partner with Clinical Operations to address site-level medical questions and enrollment challenges.
- Assist with development and maintenance of study training materials.
- Serve as a primary medical contact for investigators and study sites; participate in investigator meetings and site initiation visits.
- Support interactions with key opinion leaders and external experts; contribute to advisory boards and scientific discussions.
- Conduct ongoing review of accumulating safety and efficacy data; collaborate with Clinical Scientists and Biostatistics.
- Participate in blinded and unblinded data review as appropriate; contribute to interpretation and preparation of clinical study reports, publications, and presentations.
- Support regulatory submissions and health authority interactions; contribute clinical input to briefing books, responses, and inspection readiness.
- Collaborate cross-functionally (Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, Commercial) and present updates/recommendations to governance committees and senior leadership.
Qualifications
- MD, DO, or equivalent medical degree.
- 3+ years industry clinical development experience (or equivalent).
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience serving as a Medical Monitor for interventional clinical trials.
- Working knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Strong understanding of oncology drug development and clinical trial conduct.
- Excellent communication, collaboration, and problem-solving skills.
Skills/Experience (preferred)
- Experience supporting Phase 2 and/or Phase 3 oncology studies.
- Experience with rare diseases, sarcomas, or desmoid tumors.
- Experience supporting regulatory submissions and health authority interactions.
- Experience working in a matrixed, cross-functional environment.
- Ability to interpret complex clinical and safety data and translate findings into development recommendations.
Pay Range
- $287,887 - $394,941 USD.
- Serve as the primary Medical Monitor for global clinical studies.
- Provide ongoing medical review of safety, efficacy, and eligibility data.
- Evaluate SAEs, AESIs, and emerging safety signals.
- Collaborate with Pharmacovigilance to ensure timely safety assessment, signal detection, and risk management.
- Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.
- Ensure subject safety remains the primary consideration in study conduct and decision-making.
- Provide medical oversight of study execution from initiation through database lock and study reporting.
- Support protocol development and amendments, informed consent forms, and study-related documents.
- Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant study issues.
- Partner with Clinical Operations to address site-level medical questions and enrollment challenges.
- Assist with development and maintenance of study training materials.
- Serve as a primary medical contact for investigators and study sites; participate in investigator meetings and site initiation visits.
- Support interactions with key opinion leaders and external experts; contribute to advisory boards and scientific discussions.
- Conduct ongoing review of accumulating safety and efficacy data; collaborate with Clinical Scientists and Biostatistics.
- Participate in blinded and unblinded data review as appropriate; contribute to interpretation and preparation of clinical study reports, publications, and presentations.
- Support regulatory submissions and health authority interactions; contribute clinical input to briefing books, responses, and inspection readiness.
- Collaborate cross-functionally (Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, Commercial) and present updates/recommendations to governance committees and senior leadership.
Qualifications
- MD, DO, or equivalent medical degree.
- 3+ years industry clinical development experience (or equivalent).
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience serving as a Medical Monitor for interventional clinical trials.
- Working knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Strong understanding of oncology drug development and clinical trial conduct.
- Excellent communication, collaboration, and problem-solving skills.
Skills/Experience (preferred)
- Experience supporting Phase 2 and/or Phase 3 oncology studies.
- Experience with rare diseases, sarcomas, or desmoid tumors.
- Experience supporting regulatory submissions and health authority interactions.
- Experience working in a matrixed, cross-functional environment.
- Ability to interpret complex clinical and safety data and translate findings into development recommendations.
Pay Range
- $287,887 - $394,941 USD.