If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate totransform the lives of patients and their families. We are dedicated to developinglife-changing medicines for people with serious diseases — often with limited or notherapeutic options. We have a diverse portfolio of marketed medicines, including leadingtherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.Our patient-focused and science-driven approach powers pioneering research and developmentadvancements across our robust pipeline of innovative therapeutics in oncology andneuroscience. Jazz is headquartered in Dublin, Ireland with research and developmentlaboratories, manufacturing facilities and employees in multiple countries committed toserving patients worldwide. Please visitwww.jazzpharmaceuticals.comfor more information.
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 data Required Knowledge, Skills, and AbilitiesPh D 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 Win Nonlin, 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 company #LI-Remote#LI-DM1Jazz 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 lawJazz 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. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html .