Medical Director, Early Phase Clinical Development

• 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.