Director, Quantitative Clinical Pharmacologist
Upper Providence, United States
USD 183K-305K Executive-level Full Time
Tasks
- Apply FDA and ICH guidelines
- Apply clinical pharmacokinetic pharmacodynamic and modeling and simulation principles
- Apply physiologically based pharmacokinetic modeling for special populations and DDI
- Communicate modeling results with cross functional teams
- Conduct meta-analyses
- Design and interpret clinical pharmacology studies
- Design clinical development program
- Develop mathematical pharmacokinetic and pharmacodynamic models
- Develop model informed drug development approaches
- Lead clinical pharmacology and modeling and simulation activities
- Perform simulations for trial design
- Predict human dose range
- Prepare clinical investigator brochures and regulatory submission packages
- Present model based strategies to governance boards and regulators
- Write clinical trial protocols and reports
Perks/Benefits
Skills/Tech-stack
Clinical Study Design | Clinical pharmacodynamics | Clinical pharmacokinetics | Clinical study | Dose Recommendation | Drug development | Exposure-response | Exposure-response modeling | FDA Guidelines | ICH Guidelines | In-silico modeling | MATLAB | Meta-Analysis | Model-informed drug development | Modeling and Simulation | Nonmem | Pharmacometric Modeling | Physiologically Based Pharmacokinetic | R | Response Modeling | SAS | SimCYP | Study design | WinNonlin
Education
Doctor of Pharmacy | MD | PhD
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