發(fā)布時間:
2022
-
03
-
16
點擊次數(shù):
0
所屬職位：
高級副總裁 臨床策略開發(fā)部
所屬公司：
博雅輯因
個人簡介：
李云醫(yī)學(xué)博士，現(xiàn)任博雅輯因臨床策略開發(fā)高級副總裁，擁有逾20年創(chuàng)新藥臨床研發(fā)（FIH, phase I-III）和報批注冊以及管理經(jīng)驗，涵蓋基因編輯，細胞療法，小分子，單克隆抗體，免疫腫瘤療法。 李云博士于2019年初加入博雅輯因負責(zé)臨床研發(fā)和注冊，此前曾在Parexel(精鼎醫(yī)藥)全球醫(yī)藥服務(wù)部擔(dān)任醫(yī)學(xué)總監(jiān)逾10年，作為關(guān)鍵成員參與了數(shù)十個創(chuàng)新藥臨床試驗，其中超7款新藥申請在FDA和其他監(jiān)管機構(gòu)獲批, 并作為Parexel全球咨詢服務(wù)亞太臨床醫(yī)學(xué)策略專家參與了數(shù)十項新藥立項和研發(fā)咨詢,在處于各個不同階段的新藥開發(fā)項目中發(fā)揮了重要作用。李云博士并曾就職于諾華全球臨床研究部,以及羅氏中國、RPR（現(xiàn)屬賽諾菲）、西安楊森臨床研發(fā)部和新藥開發(fā)部，擔(dān)任多種職務(wù)且責(zé)任逐年遞增，促進了多個血液和腫瘤新藥在中國的獲批上市。李云博士畢業(yè)于上海第二軍醫(yī)大學(xué)（現(xiàn)海軍軍醫(yī)大學(xué)）， 擁有臨床血液專業(yè)學(xué)位和臨床醫(yī)學(xué)基礎(chǔ)學(xué)位，并有10年臨床醫(yī)生和研究教學(xué)經(jīng)驗以及2年多VC/PE醫(yī)藥投資項目篩選評估經(jīng)驗。Yun Li(MD), currently Senior Vice President of Clinical Strategical Development at EdiGene, has more than 20 years of experiences in clinical research ( FIH, phase I-III) and registration of innovative drugs, covering gene editing, cell therapy, small-molecule drugs, monoclonal antibodies and Immuno-oncology therapeutics. Dr. Li joined EdiGene in January 2019 with responsibilities of Clinical Development and Regulatory Affairs. Before then, Dr. Li served as the Medical Director in Paraxel’s global medical service for more than ten years, as one of the key members, she participated in dozens of clinical trials for innovative drugs, at least 7 of them approved by FDA or other regulatory authority. Besides, Dr. Li as the expert on clinical &medical in AP, provided strategic advices with Parexel global consulting group for dozens of projects when initiate drug development. Dr.Li had also taken R&D and management positions in clinical research and development departments in companies include Novartis(ICRO), Roche, Sanofi, and Xi’an Janssen, with increased responsibilities, she made significant contribution to several oncology and hematology new drugs approval in China. Dr. Li graduated from the Second Military Medical University with M.Sc. in Clinical hematology and B.Sc. in General Medicine, in addition, she has experiences with 10 years clinical practice/research/ teaching and more than 2 years VC/PE new drug investment screening & evaluation.