R&D - Clinical Research Director or Associate CRD-SH/BJ

DCV/NOD - Clinical Research Director (CRD)/Associate CRD (aCRD) - Beijing/ Shanghai

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Position overview:

The role of the CRD is to:

• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps; take on as necessary the aCRD role as below.

The role of the aCRD is to:

• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)

• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)

• Contribute to the Extended synopsis and Protocol for their project

• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities

• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators

• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Job Family Group: Clinical Development - Clinical Research