cartermackay Sr. Scientist, Pharmacokinetics (NJ and MA)

  1. With guidance, perform non-compartmental pharmacokinetic (PK) data analysis and reporting for regulatory submission using WinNonlin.
  2. Under direction, provide inputs to designing clinical pharmacology studies, protocol development, and provide support to study execution.
  3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III studies.
  4. 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.
  5. With guidance, provide scientific oversight of CROs with respect to PK and PK/PD tasks.
  6. 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.
  7. 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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