Clinical Pharmacology (CP) Principal Scientist

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%