DMPK Principal Scientist

Job Description

Responsible for establishing and executing strategy for non-clinical and clinical DMPK support of programs advancing from early discovery through candidate nomination and progression through Phase I clinical studies.  Manage combination of internal technical resources and external outsourced CRO support to complete early screening efforts and assemble IND packages.

Key factors for role

Primary Responsibilities

  • Apply experience and technical knowledge to project team in the development of DMPK discovery screening strategies utilizing in vitro ADME screening approaches and select in vivo PK investigations
  • 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
  • Work collaboratively with chemistry and biology team members to integrate SAR, physicochemical attributes, and mechanism of action knowledge to optimize leads and establish candidate selection criteria
  • Independently draft protocols and create study designs in support of ADME profiling and PK/PD investigations externally
  • 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
  • Maintain budget requirements/ quotes/invoices for external investigations.

Knowledge and Skill Requirements

  • PhD + 7 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 regresssion/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 such as S-ADAPT, S-ADAPT-TRAN, ADAPT IV, NONMEM, Berkeley Madonna (for Monte Carlo simulations), Phoenix WinNonlin and Non-linear mixed effect models statistical software (SPSS, Sigmastat, Graph Pad Prism and SigmaPlot) preferred.
  • Experience with assembling CTD documents as well as familiarity with FDA/EMA and ICH guidelines
  • Excellent communication/presentation/Powerpoint skills are required
  • Experience in antibacterial research preferred

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