发布时间:
2022
-
03
-
16
点击次数:
0
所属职位：
高级副总裁 临床策略开发部
所属公司：
博雅辑因
个人简介：
李云医学博士，现任博雅辑因临床策略开发高级副总裁，拥有逾20年创新药临床研发（FIH, phase I-III）和报批注册以及管理经验，涵盖基因编辑，细胞疗法，小分子，单克隆抗体，免疫肿瘤疗法。 李云博士于2019年初加入博雅辑因负责临床研发和注册，此前曾在Parexel(精鼎医药)全球医药服务部担任医学总监逾10年，作为关键成员参与了数十个创新药临床试验，其中超7款新药申请在FDA和其他监管机构获批, 并作为Parexel全球咨询服务亚太临床医学策略专家参与了数十项新药立项和研发咨询,在处于各个不同阶段的新药开发项目中发挥了重要作用。李云博士并曾就职于诺华全球临床研究部,以及罗氏中国、RPR（现属赛诺菲）、西安杨森临床研发部和新药开发部，担任多种职务且责任逐年递增，促进了多个血液和肿瘤新药在中国的获批上市。李云博士毕业于上海第二军医大学（现海军军医大学）， 拥有临床血液专业学位和临床医学基础学位，并有10年临床医生和研究教学经验以及2年多VC/PE医药投资项目筛选评估经验。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.