Immunome, Inc.
Medical Director / Senior Medical Director, Clinical Development
Bothell, Washington, United States · Director
Sponsorship not specifiedDetected 34 days ago
Clinical TrialsFDA RegulatoryPharmacovigilanceLeadershipBiostatisticsRegulatory Affairs
About the role
- The Medical Monitor will be responsible for 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.
Responsibilities
- Collaborate with Pharmacovigilance to ensure timely safety assessment, signal detection, and risk management activities.
- Support protocol development, protocol amendments, informed consent forms, and study-related documents.
- Support interactions with key opinion leaders and external experts.
- Collaborate with Clinical Scientists and Biostatistics to identify trends, data quality issues, and emerging clinical insights.
- Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
Benefits
- Medical Monitoring and Patient Safety
- Serve as the primary Medical Monitor for global clinical studies.
- Provide ongoing medical review of safety, efficacy, and eligibility data.
- Provide medical oversight of study execution from initiation through database lock and study reporting.
- Partner with Clinical Operations to address site-level medical questions and enrollment challenges.
- Serve as a primary medical contact for investigators and study sites.
Company info
- 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.
- We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
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