Responsible for supporting PK, PK/PD, PB/PK, and population PK analysis of data from early discovery through clinical development. Support of clinical programs will be done in collaboration with Associate Director of clinical pharmacology, but primary focus will be on programs in discovery and participation within research project teams.
- Design in vitro dose range/dose fractionation studies to discern PK/PD driver and early exposure-effect relationships in chemostat and hollow-fiber infection models
- Work directly with lab-based scientists to successfully design and analyze data generated with in vitro and In vivo PK/PD models to be used in support of clinical exposure targets
- Utilize appropriate in vivo allometric and/or in vitro intrinsic clearance data to predict human PK and complement analysis with PK/PD understanding to inform human dose projections
- Construct population PK model analyses utilizing clinical trial PK and demographic data to be used in support of Monte Carlo simulation and probability of target attainment assessments.
- Conduct modeling and simulation utilizing PK predictions, PK/PD understanding, and data available in the literature
- Assemble posters and presentations for external disclosure including conference attendance
Knowledge and Skill Requirements
- PhD + 2 to 3 years pharmaceutical research experience or BS/MS with 10+ years of experience
- +5 years of experience in DMPK, PK/PD, or quantitative pharmacology
- Established publication record
- Familiarity and working knowledge of pharmacokinetic modeling including non-compartmental analysis, non-linear regression/Emax modeling, Population pharmacokinetics / pharmacodynamics (PK/PD) modeling
- Experience with translational mechanism-based modeling, Monte Carlo simulations and physiologically based PK modeling preferred
- Proficiency with modeling software packages NONMEM, Phoenix WinNonlin, MatLab SimBiology and non-linear mixed effect models/statistical software
- Excellent communication/presentation/Power point skills are required