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Position:
CLINICAL PHARMACOLOGIST

Employer:
Protagonist Therapeutics

Description:

The Clinical Pharmacologist will

  • Define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of studies
  • Plan and execute clinical pharmacokinetic and pharmacodynamic analyses to support portfolio projects
  • Apply quantitative approaches to develop and implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions.
  • Participate on and provide input to project teams
  • Contribute to regulatory documents (INDs, clinical trial documents including protocols and study reports, IBs, NDAs)


Qualifications/Experience:
  • PhD (or equivalent), Medical degree, or PharmD
  • >3 years experience in pharmaceutical drug development.
  • Background in pharmaceutical sciences, pharmacometrics, mathematics, (bio)statistics, biomedical engineering, or a related field.
  • Proficiency in R, NONMEM, Phoenix WinNonlin, NLME, Matlab, SAS, or other similar applications
  • Experience in performing population PK and PK/PD analyses using pharmacometric software
  • Good working knowledge of the drug discovery and development process.
  • Scientific understanding of biopharmaceutics, ADME, and clinical pharmacology
  • Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations)
  • Experience with successful regulatory filings (IND, NDA/BLA, MAA)
  • Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development
  • Experience in experimental study design, problem solving, critical data analysis and interpretation
  • Good written and verbal communication, interdisciplinary collaboration and problem solving skills and ability to work in a fast paced environment


Location: Newark, CA

Contact: n.modi@ptgx-inc.com

Post Date: 4/6/2021 12:00:00 AM
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