5 дней назад
Medical Director, Early Phase Clinical Development (Clinical Pharmacology)
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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