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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： Title: Medical ManagerCompany/Location: Antengene Corporation/ShanghaiJob Type: Onsite, Full-time employeeReporting to: Director, Clinical DevelopmentJob PurposeProvide medical and scientific leadership to Antengene’s clinical development teamsEssential Duties and Responsibilities:-Contribute to clinical development and registration strategy for Antengene’s diverse oncology pipeline, especially for HCC in China and global markets-Provide overall medical and safety oversight of Antengene’s oncology clinical trials as assigned-Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment-Contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents-Prepare materials for investigator meetings, participate and present in investigator meetings-Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures-Assist with data safety monitoring board activities-Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriateQualification：-Graduate of an accredited medical school with at least five years of clinical development experience.-Experience writing clinical development protocols, IB and study reports preferred-Experience with medical and safety monitoring-Fluent in written and verbal EnglishContact: Please send your CV and cover letter to Peter.Qian@antengene.com 职能类别： 医药技术研发管理人员
联系方式
华闻大厦
公司信息
Antengene Corporation is a clinical-stage drug development company focusing on introducing mid- to late-stage drug candidates from abroad to China, bringing to China Food and Drug Administration (CFDA) approval and launching products for Chinese market Antengene's approach is to leverage global medical innovation from the U.S. and Europe coupled with Antengene's expertise in clinical development and commercialization in Chinese market to alleviate cost pressures of innovators, accelerate product entry into China, expand/defend the business interest of its partners in Chinese market and ultimately meet huge medical needs of Chinese patients.
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