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Position:
Senior Manager, Clinical Pharmacology

Employer:
Jazz Pharmaceuticals

Description:

This position has varying responsibilities in clinical pharmacology, pharmacokinetics and pharmacodynamics.



Qualifications/Experience:

This position has varying responsibilities in clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:

  • Providing DMPK and non-clinical PK/TK expertise
  • Participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goals
  • 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
  • Working closely with Bioanalytical Scientists, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programs

Required Knowledge, Skills, and Abilities

  • PhD, MD, or PharmD required. Experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis, preferred.
  • Strong understanding of clinical pharmacology principles and the drug development process
  • Working knowledge of Phoenix and other PK/PD software
  • 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

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.



Location: Palo Alto, California OR Philadelphia, Pennsylvania

Contact: lynette.lapola@jazzpharma.com

Post Date: 10/14/2019 3:44:13 PM
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