Medical Director, Early Phase Clinical Development

Latigo BioSan Francisco, CA
$300,000 - $330,000Onsite

About The Position

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.

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.

Nice To Haves

  • Experience in pain, neuroscience, neurology, anesthesiology, psychiatry, clinical pharmacology, or other relevant therapeutic areas preferred.

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.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

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