Director, Clinical Pharmacology ( UK or US Remote )

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description:
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 Functions/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.)
o 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 and pharmacometrics 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 …