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, 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.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 ensure 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 (e.g., 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.#J-18808-Ljbffr
