Medical Director, Early Phase Clinical Development
Location: Thousand Oaks, CA or San Francisco, CA
Reports To: Executive Director, 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 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.
Qualifications
- 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.
Personal Characteristics
- Thrives in a fast-paced, highly collaborative environment.
- Demonstrates flexibility, adaptability, and a willingness to take on new challenges.
- Prioritizes efficiency, accuracy, and execution while maintaining scientific rigor.
- Communicates clearly, proactively, and with a solutions-oriented mindset.
- Takes ownership and delivers results in a dynamic and evolving organization.
