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1) Drug Safety Team Leads (DSTLs) are responsible for developing, and implementing the nonclinical safety strategy for projects from Idea to Loss of Exclusivity (LoE). Safety strategies will be aligned with overall objectives of the TA (used synonymously with RU) in order to deliver on TA portfolio goals and stage-gate transitions. In addition, DSTLs serve as nonclinical safety Subject Matter Experts (SMEs) in collaboration with Regulatory Strategy Leads (RSLs) on dossier preparation and responses to regulatory queries. 2) DSTLs will represent DSRD on multidisciplinary project teams and will work to coordinate nonclinical safety strategies with activities of other lines (e.g. Pharm Sci, PDM) in order to achieve project team objectives and goals.
1) DSTLs will assess potential safety concerns associated with a target under consideration by the Research Unit (RU). A key deliverable is a Target Knowledge Review [TKR] for a specific target of interest to the RU. The DSTL is typically the primary author of the safety sections of the TKR, working with the DSRD Disease Area Lead (DAL), the DSRD Therapeutic Area Lead (TAL) and appropriate SMEs in DSRD and Research to provide an integrated assessment of potential safety issues and a proposed target de-risking strategy. 2) DSTLs will ensure that the DSRD TAL, is kept fully apprised of the progress of a project, both in terms of the overall picture (e.g. timelines, risk management, de-risking strategies, issues from other lines) and the details of study results. 3) DSTLs serve as the scientific and technical representatives for outsourced studies within their area of expertise for their projects. DSTL will coordinate with STRs for studies outside their area of expertise. 4) DSTLs will be the primary candidates for in-licensing reviews. 5) DSTLs will represent DSRD at project-related regulatory agency interactions.