Associate Director, Clinical Pharmacology

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 and follow @JazzPharma on Twitter. This position is responsible for efficient, innovative, clinical pharmacology, PK/PD, and/or population PK study design, analysis, interpretation, and reporting to support international regulatory submissions. You will interact with multidisciplinary groups across the company including clinical development, biostatistics, clinical operations, regulatory, non-clinical, quality and business development.Essential FunctionsThis position has varying responsibilities in clinical pharmacology, pharmacokinetics and pharmacodynamics which include but are not limited to:Assisting in participating in design of the clinical pharmacology component of drug development programs consistent with company and R&D program goalsClinical 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 filingsIdentifying and managing consultants and vendors supporting clinical pharmacology studiesEffective participation on cross functional teams representing early development department to insure integration of modern pharmacology principles into project plansWork closely with Bioanalytical Scientists, Project Managers, Clinical Researchers, Biostatisticians and Clinical Trials Managers to support clinical development programsRequired Knowledge, Skills, and AbilitiesPhD or MD or equivalent, with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysisStrong understanding of clinical pharmacology principles and the drug development process Good working knowledge of Phoenix and other PK/PD softwareAbility 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 companyJazz 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.

Created: 2021-11-29