Associate Clinical Pharmacology Director
Gilead
Responsibilities
- Author clinical pharmacology plans for assigned products in virology and pediatrics therapeutic areas
- Lead design, conduct, and cross-functional teams for clinical pharmacology studies of increasing complexity
- Design study protocols, data analysis plans, and pharmacokinetic-pharmacodynamic analyses
- Manage study timelines, resources, and implementation across internal and external study partners
- Represent clinical pharmacology expertise in regulatory agency interactions and prepare regulatory submissions
Requirements
- Bachelor's degree with 10+ years experience, or Master's with 8+ years, or PhD/PharmD with 5+ years
- PhD or PharmD in pharmaceutical sciences, pharmacology, or related discipline preferred
- Experience with pharmacokinetic analysis software such as WinNonlin
- Leadership experience with cross-functional project teams and matrix management
- Thorough knowledge of FDA, EMA regulations, ICH guidelines, and Good Clinical Practice
- Experience designing clinical pharmacology study protocols and authoring development plans
- Strong written and verbal communication skills for complex technical information
Vacancy posted 14 days ago
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