Medical Director, Early Phase Clinical Development

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.