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Associate Director, Drug Metabolism and Pharmacokinetics (DMPK)

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: January 10, 2022

Job Description:

The Associate Director, DMPK will provide DMPK leadership in the design, implementation, oversight, analysis, and reporting of nonclinical DMPK studies that support small and large molecule drug discovery and development teams. The candidate will direct and monitor the activities of CROs to perform in vitro and in vivo DMPK/ADME studies that comply with regulatory guidelines for small and large molecule registration. Additionally, the candidate will oversee the preparation of nonclinical DMPK reports and relevant components of regulatory submissions, including IND, NDA/BLA.Key Responsibilities:Represent DMPK as the subject matter expert on multidisciplinary project teams, providing technical, scientific, and strategic leadership for all stages of drug discovery and early developmentEstablish DMPK strategies that will enable project teams to achieve project goals within agreed upon timelinesProvide input into the PK/TK aspects of nonclinical pharmacology and nonclinical toxicology studiesCollaborate effectively with CROs to design and execute in vitro and in vivo studies aimed at characterizing the DMPK/ADME properties of drug candidates, ensuring studies are rigorously designed and comply with appropriate regulatory guidances (GLP, ICH, etc.)Initiate and manage contracts with CROs and academic partnersEffectively communicate DMPK data and provide interpretation of results to project teams, senior management, and regulatory authoritiesOversee the preparation of nonclinical DMPK/ADME reports and the relevant sections of documents for regulatory submissions (IND, NDA/BLA, etc)Participate in the assessment of in-licensing opportunities when requiredTravel up to 10 to 20% of time each yearMinimum Requirements:PhD in chemistry, biological sciences, pharmacology, or a related scientific disciplineDemonstrated knowledge and expertise in DMPK to support nonclinical and clinical stage programs5-10 years of relevant experience in the pharmaceutical or biotechnology industry, demonstrating a broad understanding of drug developmentThorough knowledge of FDA and ICH guidance documentsProven ability to manage CROsExcellent written and oral communication skillsAbility to think critically and solve problems independentlyAbility to navigate and work effectively in a fast-paced, matrix-team work environmentEmbody and model Jazz Pharmaceuticals' core values (integrity, collaboration, passion, pursuit of excellence, and innovation)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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Associate Director, Drug Metabolism and Pharmacokinetics (DMPK), Executive , Palo Alto, California

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