Director of Data Management Technologies (Remote)

If you are a current 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 and follow @JazzPharma on Twitter. Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application. 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 global clinical pharmacology strategy for multiple Jazz portfolio products, from research to registration and beyond. 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.) o This includes determining scope, design, planning and analysis of phase 1-4 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 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 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 Good working knowledge of software for PK / PD analysis (eg Phoenix WinNonlin, R, Experience in regulatory agency interactions Collaborative and flexible in personal interactions at all levels of the company 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. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. Remote working / work at home options are available for this role.

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