DMPK Principal Scientist
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
- 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
For more information, please contact Careers@EntasisTx.com