Job Description

Overview: If you are a Jazz employee please apply via the Internal Career site 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. Position Profile: 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, e.g., dose selection and optimization
• Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDAs, IBs, 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.
• 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, etc.)
• 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