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Bothell, Washington, United States
Posted · 20.09.2026
Greenhouse (US)

# Medical Director / Senior Medical Director, Clinical Development

Immunome, Inc.

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview We are&nbsp;seeking&nbsp;a highly motivated physician to serve as&nbsp;Medical&nbsp;Monitor for the late-stage development of varegacestat, an investigational therapy being developed for desmoid tumors. This individual will provide medical oversight for global clinical studies and serve as a key member of the Clinical Development team, partnering closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Translational Medicine.&nbsp; The Medical Monitor will&nbsp;be responsible for&nbsp;patient safety oversight, protocol implementation, investigator engagement, medical review of efficacy and safety data, and contribution to regulatory interactions. This position offers an opportunity to play a significant role in the registration and global development strategy of a potentially first-in-class therapy addressing a significant unmet medical need.&nbsp; &nbsp; Responsibilities Medical Monitoring and Patient Safety&nbsp; Serve as the primary Medical Monitor for global clinical studies.&nbsp; Provide ongoing medical review of safety, efficacy, and eligibility data.&nbsp; Evaluate and assess serious adverse events (SAEs), adverse events of special interest (AESIs), and emerging safety signals.&nbsp; Collaborate with Pharmacovigilance to ensure&nbsp;timely&nbsp;safety assessment, signal detection, and risk management activities.&nbsp; Participate in Safety Review Committees, Data Monitoring Committees, and other governance forums as needed.&nbsp; Ensure subject safety&nbsp;remains&nbsp;the primary consideration in study conduct and decision-making.&nbsp; Clinical Trial Conduct&nbsp; Provide medical oversight of study execution from initiation through database lock and study reporting.&nbsp; Support protocol development, protocol amendments, informed consent forms, and study-related documents.&nbsp; Review protocol deviations, eligibility questions, endpoint assessments, and other medically relevant study issues.&nbsp; Partner with Clinical Operations to address site-level medical questions and enrollment challenges.&nbsp; Assist&nbsp;with development and maintenance of study training materials.&nbsp; Investigator and External Engagement&nbsp; Serve as a primary medical contact for investigators and study sites.&nbsp; Participate in investigator meetings, site initiation visits, and key study governance meetings.&nbsp; Support interactions with key opinion leaders and external experts.&nbsp; Contribute to advisory boards and scientific discussions relevant to the development program.&nbsp; Data Review and Interpretation&nbsp; Conduct ongoing review of accumulating safety and efficacy data.&nbsp; Collaborate with Clinical Scientists and Biostatistics to&nbsp;identify&nbsp;trends, data quality issues, and emerging clinical insights.&nbsp; Participate in blinded and unblinded data review activities as&nbsp;appropriate.&nbsp; Contribute to interpretation of study results and preparation of clinical study reports, publications, and scientific presentations.&nbsp; Regulatory and Cross-Functional Leadership&nbsp; Support preparation of regulatory submissions and health authority interactions.&nbsp; Contribute clinical input into briefing books, responses to regulatory questions, and&nbsp;inspection&nbsp;readiness activities.&nbsp; Collaborate with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Biometrics, and Commercial colleagues to support integrated product development.&nbsp; Present clinical updates and recommendations to internal governance committees and senior leadership.&nbsp; &nbsp; Qualifications MD, DO,&nbsp;or equivalent medical degree.&nbsp; A minimum of 3+ years industry clinical development experience, or equivalent experience. Board certification or training in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty.&nbsp; Experience serving as a Medical Monitor for interventional clinical trials.&nbsp; Working knowledge of GCP, ICH guidelines, and global regulatory requirements.&nbsp; Strong understanding of&nbsp;oncology&nbsp;drug development and clinical trial conduct.&nbsp; Excellent communication, collaboration, and problem-solving skills.&nbsp; Knowledge and Skills Experience supporting Phase 2 and/or Phase 3 oncology studies.&nbsp; Experience with rare diseases, sarcomas, or desmoid tumors.&nbsp; Experience supporting regulatory submissions and health authority interactions.&nbsp; Experience working within a matrixed, cross-functional environment.&nbsp; Demonstrated ability to interpret complex clinical and safety data and translate findings into development recommendations.&nbsp; Washington State Pay Range$287,887&mdash;$394,941 USDE/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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