Clinical Pharmacology Senior Advisor
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Job Summary
Seeking a full-time remote Clinical Pharmacology Senior Advisor, the role involves providing expert input on pharmacokinetics and pharmacodynamics to project teams, conducting analyses for clinical studies, and drafting regulatory documents while collaborating with cross-functional teams.
Key responsibilities
- Provide clinical pharmacology and PK/PD input to project teams for dose and study design decisions
- Conduct and interpret PK analyses and develop structural models for Phase 1-2 studies
- Draft PK/PD sections of clinical development plans and collaborate with various scientific experts
Required qualifications
- PhD or PharmD in Clinical Pharmacology, Pharmacometrics, or related field, or a relevant graduate degree with significant experience
- 3+ years of industry experience in clinical pharmacology or pharmacometrics
- Solid knowledge of PK/PD theory, ADME, and drug interaction mechanisms
- Hands-on proficiency with relevant software such as NONMEM or Phoenix WinNonlin
- Working knowledge of FDA and ICH guidance related to clinical pharmacology
Complete Job Description
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