Lead Medical Director, Phase 1 Clinical Development

Latigo Bio; San Francisco (CA); On-site; USD 250,000 - 360,000; Full time

Job summary

Latigo Bio is seeking a Medical Director, Early Phase Clinical Development to provide scientific and medical leadership across Phase 1 and clinical pharmacology programs. Based in Thousand Oaks, CA or San Francisco, CA, you will work with Clinical Pharmacology, Clinical Operations, Statistics, Pharmacovigilance, and Regulatory teams to guide study design, safety oversight, and data interpretation.

The ideal candidate will have an MD, active license, at least five years in clinical development,

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.
• Demonstrated experience supporting FIH, SAD/MAD, food effect, TQT, DDI, hepatic impairment and renal impairment 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 areas.

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, PK, 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.

Skills

Medical monitoring

Regulatory understanding

Clinical pharmacology

Cross-functional collaboration

PK/PD data interpretation

Education

MD or equivalent medical degree

Active medical license preferred

Job description

Latigo Bio is seeking a Medical Director, Early Phase Clinical Development to provide scientific and medical leadership across Phase 1 and clinical pharmacology programs. Based in Thousand Oaks, CA or San Francisco, CA, you will work with Clinical Pharmacology, Clinical Operations, Statistics, Pharmacovigilance, and Regulatory teams to guide study design, safety oversight, and data interpretation.

The ideal candidate will have an MD, active license, at least five years in clinical development,