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    Associate Director, Pharmacometrics - Ottawa, Canada - Jazz Pharmaceuticals

    Jazz Pharmaceuticals
    Jazz Pharmaceuticals Ottawa, Canada

    3 weeks ago

    Default job background
    Full time
    Description

    Brief Description:

    This position is responsible for leading efficient, innovative population PK, PK/PD, exposure-response plan, analysis, interpretation, and reporting to support international drug development programs. Working through cross-functional teams, this individual will lead the overall pharmacometrics strategy for multiple Jazz portfolio products, from research to registration and beyond.

    Essential Job Functions:

    Job Responsibilities

  • Development of the pharmacometrics strategy of multiple programs
  • Design, perform, interpret and report population PK, PK/PD and exposure-response analyses
  • Provide hands-on population PK and PK/PD modeling and simulation support for development projects, ., dose selection and optimization
  • Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA's, IB's, . This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
  • Plan, prepare and review drug development plans and regulatory filings
  • Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents
  • Address queries from regulatory agencies during reviews and inspections
  • Identify and manage consultants and vendors supporting pharmacometrics analyses
  • Effective participation on cross functional teams to ensure effective integration of Model Informed Drug Development (MiDD) principles

    • Required Knowledge, Skills, and Abilities

  • PhD or PharmD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic- pharmacodynamic data analysis
  • Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
  • Prior working experiences in performing modeling and simulation tasks using software for PK/PD analysis (eg, NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK Sim,
  • Experience in regulatory agency interactions is plus
  • Ability to work both independently and collaboratively in a multidisciplinary team environment
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment
  • Excellent written and oral communication skills including good presentation skills
  • Embody and model Jazz core values

    • FOR CANADA-BASED CANDIDATES ONLY

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