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Associate Director, Clinical Pharmacology

Company: Jazz Pharmaceuticals PLC
Location: Palo Alto
Posted on: October 14, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
  • Contribute to the development of clinical pharmacology strategy of programs
  • Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA's, IB's, etc.)
  • 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. Planning, preparing and reviewing drug development plans and regulatory filings
  • Identifying and managing consultants and vendors supporting clinical pharmacology studies
  • Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans
  • Work closely with Bioanalytical Scientists, Data Managers, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs
  • 10% to 20% Travel Required
    • PhD or MD with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis
    • Strong understanding of clinical pharmacology principles and the drug development process
    • Good working knowledge of Phoenix and other software for PK/PD analysis
    • Ability to work both independently and on strong cross functional teams
    • Demonstrated superior oral and written presentation skills required
    • Collaborative and flexible in personal interactions at all levels of the company

Keywords: Jazz Pharmaceuticals PLC, Palo Alto , Associate Director, Clinical Pharmacology, Executive , Palo Alto, California

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