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Drug Safety Therapeutic Lead (DSTL)

応募後で応募 求人ID R0021586 掲載日 07/30/2020 Location:Cambridge, Massachusetts

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Job Description

For Global DSRE

  • Representation of their Therapeutic Area of focus as an engaged member of the DSRE Leadership Team
  • Regular and active participation in appropriate DSRE meetings to give briefing updates on therapeutic area status, critical issues and major milestones
  • Participation in Protocol Review meetings to explore best practices in protocol design tailored to a project and to support DSRE Project Team Representatives in experimental design and data interpretation
  • Support and mentorship of DSRE Project Team Representatives by providing input and guidance on scientific and regulatory strategy
  • Review of study reports and regulatory documents for scientific accuracy and consistency of message
  • Interacts with the Global Head, Site Heads, fellow DSTLs and/or Head of Discovery Toxicology to address questions on strategy and potential safety issues as appropriate

For a specific Therapeutic Area:

  • Provides scientific and strategic guidance, and matrix oversight for all DSRE Project Team Representatives in Neuroscience therapeutic area
  • Guides efficient design and execution of studies in support of drug candidates
  • Oversees Neuroscience project portfolio as the DSRE Leadership Team accountable person, ensuring that the DSRE strategy is in alignment with other functions in discovery and development
  • Guides, mentors, and provides performance feedback for DSRE Project Team Representatives Interact directly with DDU and TAU head (or designee) to determine goals, strategy and execution of the development of drug candidates
  • Provide scientific and strategic expertise to DSRE Project Team Representatives for the development of TA drug candidates
  • Review and advise on data, reports, scientific conclusions and presentations
  • Approve DSRE components of drug safety strategy for all Neuroscience projects at appropriate milestones
  • Keep current on the latest trends in the competitive and regulatory landscape particularly as it relates to Neuroscience
  • Align goals and resources with DDU and TAU, and communicate those needs to DSRE Site Head(s), and other functional heads, as needed
  • Consults with Head of Discovery Toxicology, Investigative Toxicology and Site Heads (or designees) to ensure that appropriate personnel from their lines are assigned to projects at the appropriate time.
  • Review and approve regulatory documents and correspondence

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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