cartermackay Sr. Scientist, Pharmacokinetics (NJ and MA)
- With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
- Under direction, provide inputs to designing clinical pharmacology studies, protocol development, and provide support to study execution.
- Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III studies.
- Under direction, devise PK and PK-PD analysis plan and conduct analyses to describe PK in target patient population and explore PK-PD relationships to support dose selection for drug candidates in development.
- With guidance, provide scientific oversight of CROs with respect to PK and PK/PD tasks.
- Under direction, evaluate the relationship between exposure and pharmacodynamic (PD) properties for compounds from discovery to proof of activity to late stage Phase 3 drug development.
- Under direction, conduct PK and PK-PD analyses and author reports to support global regulatory submission documents for compounds under drug development.
Required: PhD with 0-5 years experience. Level commensurate with the individual candidate and internal nomenclature
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