临床医学负责人-Cliniccal Science Leader 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Responsibility：A.Accountable for the domestic and international clinical development strategy with corresponding molecule(s) in oncology area from clinical perspective：1）Prepare clinical documents required from different health authority with effective interaction；2）Design clinical development plan and study protocol；3）Monitor and review medical data for clinical trials；4）Analyze, present, and interpret the data from ongoing and/or published studies；5）Collaborate actively with cross function teams, such as drug safety, regulatory, clinical operation ,data management, statistical analysis etc.；6）Publish data in domestic and/or international academic platform with abstract, poster, presentation etc.B.Evaluate opportunities and plan on approved molecules for the development of new indicationsC.Participate and support strategic planning and implementation for the disease area among oncology areaD.Participate and support the research, in/out licensing of new targets or drugs in oncology area led by business development and/or preclinical research teamE.Interact with external experts from healthcare organization and/or institutions in oncology area (e.g., Center of Drug Evaluation, Advisory Committee, Key Opinion Lead)F.Holding CRO/Partners accountable for the high quality standards of their deliverablesQualification：A.Certificates as clinical doctor with practice experience in oncology areaB.At least 3-year experience of clinical drug development in pharmaceuticals/biotech industry, including designing and implementation of clinical projects in early/late stage, or more than 5 years clinical experience with specific therapeutic areaC.Experience of preparation and implementation for clinical trial application and/or new drug applicationD.Ability to drive the delivery of commitment in a matrix teamE.Good written and oral communication skill in both Chinese and English in the negotiation, presentation, and authoring process with relevant cross function team, medical experts, as well as regulatory reviewersF.Sufficient knowledge of business process, regulatory, and compliance related to drug developmentG.Competency on good decision making, influencing, and execution in the changing business environment and being comfortable for uncertainties through excellent risk management skill 职能类别： 其他

联系方式

张江高科李冰路67弄11号楼

公司信息

罗欣生物科技（上海）有限公司是山东罗欣药业集团股份有限公司（在香港上市的公司）的全资子公司，是罗欣集团为了满足日益增长的研发需要，于2014年6月在上海成立的研发公司。罗欣生物科技将定向承担母公司的研发业务，包括化学药和生物药。我们需要各类研发和管理人才，在此，我们真诚邀请您的加盟，共同创造新的辉煌！ 罗欣集团是集药品研发、生产、贸易融为一体的大型医药企业集团，由山东罗欣药业股份有限公司、山东明欣医药有限公司、山东罗盛医药有限公司等十几家公司组成。企业被国家商务部评为“aaa①”级诚信企业，“罗欣”商标被国家工商总局商标局认定为“中国著名商标”，多次被国家、省、市授予“aaa级信誉企业”、“守合同重信用企业”、“文明单位”、“医药行业先进单位”等荣誉称号。 山东罗欣药业集团股份有限公司为集团骨干企业，是由山东罗欣制药厂改制重组、罗欣医药集团有限公司控股、联合沈阳药科大学等共11家发起人共同设立的股份制公司，是严格按照现代企业制度和国家gmp要求组建的制药企业。公司股份于2005年12月在香港h股挂牌上市，自2006年开始公司连续进入中国制药工业百强企业和中国十大最具成长力药企，是国家重点高新技术企业。目前，公司建有粉针剂、冻干粉针剂、大容量注射剂、小容量注射剂、固体制剂、化学原料药等三十多条生产线，已有十几个剂型、200多个产品规格上市，其中***新药46个。公司可年产粉针剂10亿支，冻干粉针剂3亿支，大容量注射剂4亿瓶，小容量注射剂5亿支，片剂25亿片，胶囊剂20亿粒，颗粒剂3亿袋，干混悬剂8000万袋，化学原料药300吨。 最新动态：山东罗欣药业集团股份有限公司在2014中国化学制药行业工业企业综合实力百强中位列第23位。产品——注射用兰索拉唑（商品名/商标名：兰川）被授予“2014中国化学制药行业消化系统类优秀产品品牌“。

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企业入驻日期： 2017-11-09

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