Job Title
Clinical Pharmacology & Pharmacometrics Scientist

Date Posted
4/21/2022

TimeZone
Pacific
  • Responsible for developing the overall clinical pharmacology and pharmacometrics strategy and overseeing modeling and data analysis for clinical development programs.
  • Oversees preparation of all relevant clinical pharmacology and modeling sections of clinical and regulatory documents, including early and late development plans, protocols and IBs, clinical study reports, INDs and other regulatory submissions.
  • Accountable for pharmacokinetic and PK/PD data analyses of translational datasets and clinical study data using standard industry data analysis software.
  • Responsible for developing models and tools to support clinical development, including selecting starting dose in FIH trials based on allometric scaling or PBPK modeling, assessing exposure-response for dose selection during and post POC, conducting population PK analyses, and contributing to dose selection for Phase II and III clinical trials based on PK, PD biomarker, safety and efficacy data.


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