Brief Description:This position is responsible for leading efficient, innovative, clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 through working with cross-functional team members.Essential Job Functions:Job ResponsibilitiesDevelopment of the clinical pharmacology strategy of multiple programs spanning from candidate nomination for GLP toxicity studies through phase 4Support clinical study protocol (phase 1-4) development, PKPD data analysis/interpretation, and study reportServe as the clinical pharmacology Lead at cross function teams, and responsible for the dose selection and rationale in phase 1 studies and contribute to dose selections in clinical studies beyond phase 1Work with the pharmacometrics lead and relevant cross-function teams to plan and support PKPD modeling for internal or regulatory decision makingsContribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documentsAddress queries from regulatory agencies during reviews and inspectionsIdentify and manage consultants and vendors supporting clinical pharmacology studiesContribute to the timely publication and/or presentation of clinical pharmacology and pharmacometrics dataRequired Knowledge, Skills, and AbilitiesPhD or MD with significant years of experience in

clinical

pharmacokinetic and pharmacokinetic-pharmacodynamic

studies and

data analysis/interpretationsStrong understanding of clinical pharmacology and pharmacometrics principles and the drug development processGood 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 teamsExperience in regulatory submissions and agency interactions related to INDs, CTDs, NDAs or BLAsExcellent written and oral communication skills including good presentation skillsCollaborative 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

#J-18808-Ljbffr