Description
+ Design and implement China AD biomarker/translational plans, and explore and identify academia partners for clinical validation.
+ On-site support PI in the validation studies with other relevant internal functions, eg. DHR venture, CA, etc.
+ Lead the development of clinical protocols and related SOWs. Provides strategic expertise to quantify the benefits, risks, value, and uncertainty of clinical trials.
+ Ensure efficient and effective management of project information, quality standards, and integrity of information interpretation.
+ Work closely with global and local R&D team to provide up-to-date clinical validation progress and answer key scientific questions.
+ Provides excellent representation of scientific input to enable successful China-focused clinical development and registration decisions.
+ Support business case of Beacon stage 3 in any case novel marker discovered from PI’s research and support late translational research to DHR/BCCE.
+ Support regulatory submissions and regulatory interactions as needed.
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