Director, Clinical Pharmacology

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 17, 2021

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

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

Essential Job Functions:

Job Responsibilities

• Development of the clinical pharmacology strategy of multiple 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
• Direct and manage the activities of staff within the Clinical Pharmacology group
• 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 clinical pharmacology studies
• Effective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plans

Required Knowledge, Skills, and Abilities

• PhD or MD with 10+ 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 software for PK/PD analysis (eg Phoenix WinNonlin, R, ADAPT and NONMEM)
• Ability to work both independently and on strong cross functional teams
• Experience in regulatory agency interactions
• Excellent written and oral communication skills including good presentation skills
• Collaborative and flexible in personal interactions at all levels of the company

***The position can be based in Philadelphia, PA or Palo Alto, CA***

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Director, Clinical Pharmacology, Other , Palo Alto, California