Medical Director / Senior Medical Director, Clinical Development
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
- Medical Monitor for late-stage development of varegacestat for desmoid tumors; provide medical oversight for global clinical studies and partner with Clinical Development teams.
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.
- Ensure subject safety is the primary consideration.
- Provide medical oversight from initiation through database lock and study reporting.
- Support protocol development/amendments, informed consent forms, and study documents.
- Review protocol deviations, eligibility questions, and endpoint assessments.
- Partner with Clinical Operations on site medical questions and enrollment challenges.
- Support development/maintenance of study training materials.
- Serve as primary medical contact for investigators and study sites.
- Attend investigator meetings, site initiation visits, and governance meetings; support external expert interactions.
- Conduct ongoing review of safety/efficacy data and collaborate with Clinical Scientists/Biostatistics.
- Participate in blinded/unblinded data review as appropriate; contribute to study result interpretation.
- Support regulatory submissions/health authority interactions and contribute clinical input to briefing books and responses.
- Present clinical updates and recommendations to governance and senior leadership.
Qualifications
- MD, DO, or equivalent.
- 3+ years industry clinical development experience (or equivalent).
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience as a Medical Monitor for interventional clinical trials.
- Working knowledge of GCP, ICH, and global regulatory requirements.
- Strong understanding of oncology drug development and clinical trial conduct.
Knowledge and Skills (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 in matrixed, cross-functional environments.
- Ability to interpret complex clinical and safety data and translate into recommendations.
- Medical Monitor for late-stage development of varegacestat for desmoid tumors; provide medical oversight for global clinical studies and partner with Clinical Development teams.
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.
- Ensure subject safety is the primary consideration.
- Provide medical oversight from initiation through database lock and study reporting.
- Support protocol development/amendments, informed consent forms, and study documents.
- Review protocol deviations, eligibility questions, and endpoint assessments.
- Partner with Clinical Operations on site medical questions and enrollment challenges.
- Support development/maintenance of study training materials.
- Serve as primary medical contact for investigators and study sites.
- Attend investigator meetings, site initiation visits, and governance meetings; support external expert interactions.
- Conduct ongoing review of safety/efficacy data and collaborate with Clinical Scientists/Biostatistics.
- Participate in blinded/unblinded data review as appropriate; contribute to study result interpretation.
- Support regulatory submissions/health authority interactions and contribute clinical input to briefing books and responses.
- Present clinical updates and recommendations to governance and senior leadership.
Qualifications
- MD, DO, or equivalent.
- 3+ years industry clinical development experience (or equivalent).
- Board certification/training in Oncology, Hematology/Oncology, Internal Medicine, or related specialty.
- Experience as a Medical Monitor for interventional clinical trials.
- Working knowledge of GCP, ICH, and global regulatory requirements.
- Strong understanding of oncology drug development and clinical trial conduct.
Knowledge and Skills (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 in matrixed, cross-functional environments.
- Ability to interpret complex clinical and safety data and translate into recommendations.