Назад
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5 дней назад

Medical Director, Early Phase Clinical Development (Clinical Pharmacology)

Формат работы
hybrid
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Medical Director, Early Phase Clinical Development (Clinical Pharmacology): Leading medical oversight and interpretation of Phase 1 and clinical pharmacology studies, including first-in-human, SAD/MAD, food effect, TQT, DDI, and organ impairment studies, with an accent on safety review, dose escalation, and clinical data interpretation. Focus on serving as Medical Monitor, designing early-phase protocols, evaluating PK/PD and safety data, and supporting regulatory submissions.

Location: Hybrid in Thousand Oaks, California or San Francisco, California

Company

hirify.global is a biotechnology company advancing clinical development programs.

What you will do

  • Serve as Medical Monitor for Phase 1 and clinical pharmacology studies.
  • Provide medical oversight of study conduct, adverse events, serious adverse events, laboratory abnormalities, and emerging safety data.
  • Partner with Clinical Pharmacology on study design, dose escalation, protocol development, and interpretation of clinical pharmacology data.
  • Provide medical input on protocols, informed consent forms, investigator brochures, clinical study reports, and other development documents.
  • Review PK, PD, biomarker, safety, and other clinical data; participate in Safety Review Committees and study governance.
  • Present results, answer investigator and site medical questions, and contribute to regulatory submissions and health authority responses.

Requirements

  • MD or equivalent medical degree.
  • Minimum 5 years of industry experience in clinical development.
  • Experience supporting or serving as Medical Monitor for Phase 1 and clinical pharmacology studies, preferably including first-in-human, 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.
  • Active medical license preferred; experience in pain, neuroscience, neurology, anesthesiology, psychiatry, clinical pharmacology, or another relevant therapeutic area is preferred.

Culture & Benefits

  • Fast-paced and highly collaborative biotechnology environment.
  • Work closely with Clinical Pharmacology, Clinical Operations, Statistics, Pharmacovigilance, and Regulatory teams.
  • Role emphasizes flexibility, adaptability, efficient decision-making, scientific rigor, and clear communication.

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