Therapeutic Data Strategy Director
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About The Position
The Therapeutic Data Strategy Director (TDSD) bridges science and operations by defining how the clinical data strategy is operationalized across the complete data flow within Global Clinical Operations (GCO). The TDSD is responsible for ensuring data regulatory compliance, the availability of End-to-End (E2E) standards, that instruments and devices are thoroughly discussed, defined, and finalized prior to the database build and that the operational impact of any new changes are known, costed, mitigated, and captured in the appropriate knowledge database. In collaboration with the GPT, the TDSD aligns on the fit for purpose data package as part of a program / indication level quality by design to support data strategy needs in the drug development lifecycle of a molecule or across therapeutic area (TA) within an assigned unit in Novartis. This role is accountable for the end-to-end data product, ensuring application of Novartis clinical data standards and defining the clinical data acquisition and data review, analysis, and reporting strategy to support the submission of our clinical programs.
