Responsible for: Medial/clinical evaluation for potential in license projects (30+). Development strategy, pivotal study design and NDA dossier preparation of one innovative medical device (Relivion).

Serve as global/local safety physician for the global phase 3 development program as well as China local studies. Work with vendor to process the cases, query as necessary and report the health authority for the SUSAR cases. Build up China local PV system in accordance with the ICH and other international guidance. Establish a full functional team to cover the whole process of pharmacovigilance. Build up the team from 0 to 10.Communicate with local affiliates/sites/investigators/other… Show more Serve as global/local safety physician for the global phase 3 development program as well as China local studies. Work with vendor to process the cases, query as necessary and report the health authority for the SUSAR cases. Build up China local PV system in accordance with the ICH and other international guidance. Establish a full functional team to cover the whole process of pharmacovigilance. Build up the team from 0 to 10.Communicate with local affiliates/sites/investigators/other stake holder on the safety questions/issues. Show less

Work as the project lead and clinical lead in multiple disease areas including CNS immunology diabetes biosimilar and rare disease. Make the China development strategy for new compounds with cross functions. Supervise the ongoing clinical trials interprete the study data and defend in front of health authorities. Build up the relationship with KOLs in new.disease area.

Help to build up China development strategy for new product in dementia, depression, pain disorder and other related disseases.Work closely with global team to give China inputs and access the feasibility of conducting clinical trials in this therapeutic area.Build up relationship with key thought leaders in the related disease area.

resident

Resident