Manager, Quantitative Clinical Pharmacology
- Experience Level
- Experienced (non-manager)
RBW are working in close collaboration with a market leading pharmaceutical company that require a Clinical Pharmacologist with a strong background in Modelling and Simulation. This opportunity will allow you to lead projects from FIH studies through to submission for multiple drug development programs. The main focus of this role will be to follow clinical pharmacology activities and implement PK/PD modelling and simulation techniques when required.
- Design clinical pharmacology studies and contribute to the clinical development program.
- Implement clinical pharmacology strategy by interacting with cross functional teams including statisticians, DMPK etc.
- Write sections of study protocols and contribute to regulatory submission packages including IBs and CTDs.
- Develop Population PK/PD modelling and simulation techniques.
- Interact with health authorities to defend the quantitative clinical pharmacology plan.
- Educated to PhD with a minimum of 2 years Post Doc experience.
- Strong PK/PD background and experience contributing to clinical pharmacology studies.
- Proficient user of modelling software including NONMEM, R etc.
- Previous experience contributing to regulatory submission documents.
- Strong communication skills.
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