Sr Director, Drug Metabolism

职位描述

Essential Duties and Job Responsibilities:

• Through guidance of other staff and external resources, and through direct laboratory work conduct studies to determine the kinetics of metabolism of drug candidates and to determine the roles of various enzymes in the metabolic profiles of those compounds.
• Serve as a drug metabolism and enzyme kinetics subject matter expert for multiple dynamic cross-functional teams, to define strategies to achieve target product profiles, integrate in vitro and in vivo drug disposition data, interpretation, and give presentations to teams.
• Working largely independently, evaluate DMPK data from external opportunities and provide necessary opinions on the assets (e.g. prediction of human PK and dose, PKPD, DDI liability etc.).
• Work closely with internal and external resources to assure timely delivery of high-quality data.
• Provide clear verbal communication of results and strategies at group, department, project team and management level. Write research reports and regulatory documents.
• Contribute to science through conference presentations and publication of new findings.

Knowledge, Experience and Skills:

• Requires a highly motivated individual with PhD degree in life sciences with 11 - 15 years of post-doctoral and/or industry experience directly related to the Specific Responsibilities listed above (hands-on experience and deep knowledge of enzymology and enzyme kinetics, plus proven application to problems in research and development).

• A significant advantage would be hands-on experience in application of the enzymology data in physiologically-based PK (PBPK) modeling (using e.g. Simcyp, GastroPlus or custom models)

• Demonstrates excellent scientific verbal and technical communication, and interpersonal skills. Must be organized, pay attention to details and have strong organizational and planning skills.
• Expertise and experience in one or more of the following areas:
  • Experience in drug development, authoring documents for regulatory authorities
  • Deep understanding of the principles, theories and approaches of PK, drug disposition and drug interactions. Proven application of modeling methods for quantitative translation using Simcyp, GastroPlus and/or general kinetic modeling programs.
  • State of the art bioanalysis by LC/MS and related techniques