Backed by 5AM Ventures.
About the role
The Medical Director will support the planning, execution, oversight, and interpretation of Phase 1 and clinical pharmacology studies across the company's development programs. This role will work closely with Clinical Pharmacology, Clinical Operations, Statistics, Pharmacovigilance, and Regulatory teams to provide medical leadership for first-in-human and other early clinical studies, including SAD/MAD, food effect, thorough QT (TQT), drug-drug interaction (DDI), hepatic impairment, and renal impairment studies.
What they're looking for
- Serve as Medical Monitor for Phase 1 and clinical pharmacology studies
- Provide medical oversight for study conduct, including review of adverse events, serious adverse events, laboratory abnormalities, and emerging safety data
- Partner closely with Clinical Pharmacology on study design, dose escalation decisions, protocol development, and interpretation of clinical pharmacology data
- Provide medical input into study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical development documents
- Respond to investigator and site medical questions in a timely manner
- Participate in Safety Review Committees and other study governance activities
More about this role
Medical Director, Early Phase Clinical Development
The Medical Director will support the planning, execution, oversight, and interpretation of Phase 1 and clinical pharmacology studies across the company's development programs. This role will work closely with Clinical Pharmacology, Clinical Operations, Statistics, Pharmacovigilance, and Regulatory teams to provide medical leadership for first-in-human and other early clinical studies, including SAD/MAD, food effect, thorough QT (TQT), drug-drug interaction (DDI), hepatic impairment, and renal impairment studies.
The ideal candidate has significant experience supporting and/or serving as Medical Monitor for Phase 1 and clinical pharmacology studies and is comfortable working in a fast-paced biotechnology environment where collaboration, flexibility, and efficient decision-making are essential.
Primary Responsibilities
- Serve as Medical Monitor for Phase 1 and clinical pharmacology studies.
- Provide medical oversight for study conduct, including review of adverse events, serious adverse events, laboratory abnormalities, and emerging safety data.
- Partner closely with Clinical Pharmacology on study design, dose escalation...
Browse similar: Startup jobs · San Francisco Bay Area