VP /SVP Medical China or US based

This role is responsible for providing

medical expertise on different stages of clinical trials to accelerate the fast

growth of Duality, including study design, protocol development, execution,

medical monitoring, as well contributing to clinical development planning and

strategy.

l  Set up and build up the medical team to meet the

business needs per business needs;

l  Ensure that projects are carried out within the

set timeline, quality standards and budget, and in accordance with business

requirements;

l  Lead the development of clinical development

plans, proof-of-concept strategies, and registration strategies for oncology

projects; keep the CDP up to date by regular review;

l  Oversight or leads the development of clinical

study protocol synopsis, protocols, and protocol amendments, medical documents,

such as IB, CSR, MMP etc. Review and approve other function documents that need

medical input, such as ICF, CRF, PD documents, SAP, DVP, dry run, DSUR etc. Contributes

to the clinical sections of the IND/NDA/BLA CTD, briefing packages for

regulatory meetings;

l  Lead and/or conduct medical monitoring to ensure

data review quality (e.g. participant eligibility review, Protocol Deviation

review, efficacy and safety review such as efficacy variable; Adverse Events

(AEs); Concomitant medications), participant safety and data accuracy;

l 

Ensure comprehensive

safety review and safety follow up;

l  Where possible (appropriate language skills exist),

check critical items in the translation (e.g. clinical/preclinical research

terminology) and provide comments back to the translation vendor;

l  Oversee function-related vendor selection and supervise

medical related work regardless of whether it is implemented in-house or

out-sourcing to third party organizations;

l  Answers medical questions raised by HA/EC/IRBs

and sites; identifies the need for protocol amendment and maintains appropriate

compliance with protocols;