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
* Development of the clinical pharmacology strategy of multiple programs spanning from candidate nomination for GLP toxicity studies through phase 4
* Support clinical study protocol (phase 1-4) development, PKPD data analysis/interpretation, and study report
* Serve 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 1
* Work with the pharmacometrics lead and relevant cross-function teams to plan and support PKPD modeling for internal or regulatory decision makings
* 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
* Contribute to the timely publication and/or presentation of clinical pharmacology and pharmacometrics data
Qualifications
* PhD or MD with significant years of experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic studies and data analysis/interpretations
* 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 submissions and agency interactions related to INDs, CTDs, NDAs or BLAs
* Excellent written and oral communication skills including good presentation skills
* Collaborative and flexible in personal interactions at all levels of the company
Jazz Pharmaceuticals is a global biopharma 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.
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