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Pharmacometrician

United States - New Jersey - Parsippany, United States - California - Foster CityClinical Development & Clinical OperationsRegular

Описание вакансии

Pharmacometrician

*This is a site-based position located in Foster City, CA or Parsippany, NJ

As a Pharmacometrician your main role should be performing a variety of pharmacometrics analyses at Gilead. You will have unparalleled opportunity to be involved with several aspects the product development process. From first-in human dose projections in partnership with DMPK through approval and post-marketing activities, you will provide input into a breadth of products across Gilead portfolio. We seek to provide a rewarding career and a continuous learning

experience.

Responsibilities

  • The candidate will be exposed and mentored on the development and implementation of clinical pharmacology and modeling/simulation strategies for small/large molecules in all stages of drug development.
  • The candidate should possess strong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (population modelling, PK, E-R, literature meta-analyses, Clinical Trial Simulation, etc). The candidate should be familiar with modeling and simulation software programs such as (NONMEM, R, LATEX, MATLAB, etc). Experience on the application of physiologically based pharmacokinetic (PBPK) modeling analysis to support dose decisions in clinical trials and simulation of drug-drug interactions for quantitative risk assessment is a plus.
  • Candidates will grow on the role with the goal of being able to anticipate problems that may occur in clinical trials and develop solutions for them using precedents or original thinking. The Pharmacometrician will work with the Clinical Pharmacologist regarding optimal implementation and conduct of clinical pharmacology studies, analysis, interpretation and reporting of clinical pharmacology summaries and modeling report to support regulatory queries, interactions and NDAs/BLAs.
  • The candidate will contribute to and represent the department on multifunctional project teams.
  • Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.
  • In-depth knowledge and understanding of the regulatory requirements for quantitative analysis, MIDD, and MI3 pilot programs is a plus.

Experience and Skills:

  • Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing. Normally receives general instructions on non-routine work and detailed instructions on routine new assignments.
  • Requires a basic understanding of drug development.
  • 0+ years of experience and an MD, PhD or PharmD degree in pharmacokinetics or a related scientific discipline.
  • 4+ years of experience and a Masters degree in pharmacokinetics or a related scientific discipline.
  • 6+ years of experience and a Bachelors degree in pharmacokinetics or a related scientific discipline.