Medical Director / Senior Medical Director, Clinical Development
Immunome, Inc.
August 29, 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 on safety assessment, signal detection, and risk management.
- Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.
- Ensure subject safety is the primary consideration in study conduct and decision-making.
- Provide medical oversight from initiation through database lock and study reporting.
- Support protocol development/amendments, informed consent forms, and study-related documents.
- Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant issues.
- Partner with Clinical Operations on site-level medical questions and enrollment challenges; assist with training materials.
- Serve as 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/efficacy data; collaborate with Clinical Scientists and Biostatistics on trends and clinical insights.
- Participate in blinded/unblinded data review as appropriate; contribute to interpretation, clinical study reports, publications, and presentations.
- Support regulatory submissions and health authority interactions; provide clinical input for briefing books, regulatory responses, and inspection readiness.
- Collaborate cross-functionally (Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, Commercial); present clinical updates and recommendations to governance committees and senior leadership.
Qualifications:
- MD, DO, or equivalent medical degree.
- 3+ years industry clinical development experience.
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience serving as 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.
Knowledge/Skills (preferred):
- Experience supporting Phase 2 and/or Phase 3 oncology studies.
- Experience with rare diseases, sarcomas, or desmoid tumors.
- Experience with regulatory submissions and health authority interactions.
- Experience in a matrixed, cross-functional environment.
- Ability to interpret complex clinical and safety data and translate findings into development recommendations.
- 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 on safety assessment, signal detection, and risk management.
- Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.
- Ensure subject safety is the primary consideration in study conduct and decision-making.
- Provide medical oversight from initiation through database lock and study reporting.
- Support protocol development/amendments, informed consent forms, and study-related documents.
- Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant issues.
- Partner with Clinical Operations on site-level medical questions and enrollment challenges; assist with training materials.
- Serve as 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/efficacy data; collaborate with Clinical Scientists and Biostatistics on trends and clinical insights.
- Participate in blinded/unblinded data review as appropriate; contribute to interpretation, clinical study reports, publications, and presentations.
- Support regulatory submissions and health authority interactions; provide clinical input for briefing books, regulatory responses, and inspection readiness.
- Collaborate cross-functionally (Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, Commercial); present clinical updates and recommendations to governance committees and senior leadership.
Qualifications:
- MD, DO, or equivalent medical degree.
- 3+ years industry clinical development experience.
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience serving as 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.
Knowledge/Skills (preferred):
- Experience supporting Phase 2 and/or Phase 3 oncology studies.
- Experience with rare diseases, sarcomas, or desmoid tumors.
- Experience with regulatory submissions and health authority interactions.
- Experience in a matrixed, cross-functional environment.
- Ability to interpret complex clinical and safety data and translate findings into development recommendations.