California Licensed Clinical Pharmacology Director
Job Summary
To support a growing biopharmaceutical company, the full-time California Licensed Clinical Pharmacology Director will manage clinical pharmacology strategies and development plans, lead dose selection for early clinical development, and oversee pharmacometrics strategies in a fully remote environment.
Key Responsibilities
- Own the clinical pharmacology strategy and development plan for each program from IND through NDA/MAA
- Lead first-in-human dose selection and escalation, integrating nonclinical data
- Execute pharmacometrics strategies, including population PK and PK/PD modeling, across all drug development stages
Required Qualifications
- PhD in Pharmacometrics, Quantitative & Clinical Pharmacology, Pharmaceutical Sciences, or a related field
- 10+ years of industry experience in clinical pharmacology and/or pharmacometrics with leadership responsibility
- Hands-on experience supporting clinical programs from first-in-human to later-stage development
- Demonstrated expertise in modeling and simulation tools (e.g., NONMEM, R, Phoenix)
- Experience authoring clinical pharmacology sections of regulatory submissions and engaging with health authorities
Complete Job Description
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