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About the Role
The Medical Director will provide medical leadership for early clinical studies, including first-in-human, SAD/MAD, food effect, TQT, DDI, hepatic impairment, and renal impairment studies. This role involves close collaboration with various teams to ensure successful study execution and interpretation.
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 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.
- Review and interpret safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker, and other clinical data to support study decisions.
- Present study results and clinical recommendations to internal teams and external stakeholders, as needed.
- Contribute to regulatory submissions and responses to health authority questions.
Requirements
- MD or equivalent medical degree.
- Active medical license preferred.
- Minimum 5 years of industry experience in clinical development.
- Experience serving as Medical Monitor for Phase 1 and clinical pharmacology studies is strongly preferred.
- Demonstrated experience supporting first-in-human (FIH), SAD/MAD, food effect, TQT, DDI, hepatic impairment, renal impairment, and other clinical pharmacology studies.
- Strong understanding of clinical pharmacology, drug development, GCP, and applicable regulatory requirements.
- Ability to interpret PK, PD, safety, biomarker, and clinical data.
- Experience in pain, neuroscience, neurology, anesthesiology, psychiatry, clinical pharmacology, or other relevant therapeutic areas preferred.
Skills
- Clinical Pharmacology
- Drug Development
- GCP
- Regulatory Requirements
- PK Data Interpretation
- PD Data Interpretation
- Safety Data Interpretation
- Biomarker Data Interpretation
- Clinical Data Interpretation
Location
- Thousand Oaks, CA
- San Francisco, CA
Work Type
- Full-time
Experience Level
- Minimum 5 years of industry experience in clinical development
- Experience serving as Medical Monitor for Phase 1 and clinical pharmacology studies is strongly preferred
Education Level
- MD or equivalent medical degree
- Active medical license preferred