Clinical Pharmacology (CP) Principal Scientist
$117k - $201.25kJohnson & Johnson
Clinical Pharmacology Principal Scientist role within Johnson & Johnson's Innovative Medicine division. Applies clinical pharmacology expertise to design studies, conduct pharmacokinetic/pharmacodynamic analyses, and support model-informed drug development across all stages of development. Reports to senior CPP leadership with potential to lead clinical pharmacology aspects of compound development teams.
Responsibilities
- Design clinical pharmacology studies and pharmacology study components aligned with regulatory guidelines
- Conduct pharmacokinetic, pharmacodynamic, and translational analyses to inform dose selection and study design optimization
- Integrate nonclinical and clinical data to influence development decisions and support patient sub-population identification
- Author clinical pharmacology sections of regulatory documents including investigator brochures and submission packages
- Manage operational elements and day-to-day execution of clinical pharmacology aspects within assigned programs
Requirements
- PhD in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, or related biological sciences with 4+ years relevant experience; or PharmD with 4+ years experience
- Understanding of pharmacokinetics, pharmacodynamics, and translational medicine principles
- Proficiency with advanced analysis methods and modeling software including NONMEM, R, Gastroplus, Simcyp, and WinNonlin
- Knowledge of model-informed drug development and pharmaceutical R&D processes
- Working knowledge of regulatory requirements and guidelines (FDA, EMEA, ICH)
- Strong oral and written communication skills for interpreting results and presenting findings
- Ability to travel 5-10%
Vacancy posted 1 day ago
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