(Senior) Director of Clinical Development 上海

月薪： 2-5万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 年终奖金
  • 股票期权
  • 定期体检
  • 绩效奖金

职位描述

职位描述： Key Responsibilities:*Collaborate with functional groups to develop and implement biomarker strategies, plans and components with the support from external CROs to enable filing and implementation of all-stage biomarker guided China clinical trials.*Evaluate, interpret and present complex scientific data to KOLs and regulatory authorities.*Collaborate with clinical and pre-clinical teams to identify, evaluate biomarker vendors and CROs and provide oversight of biomarker development program management. Provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements. Collaborates with Clinical Operations to ensure compliance related to biomarker-related sample collection and evaluation.*Direct and manage the implementation of overall biomarker/companion diagnosis development involving in-house non-clinical, clinical team, hospitals and KOLs.Qualifications:*Master Degree or above in biological sciences or related field with 10 or more years of related experience.*Experienced in oncology drug development highly preferred.*Must have at least 10 years industry experience in fit-for-purpose clinical assay development, validation and implementation in support of multisite clinical trials. China implementation experience is highly desirable.*Must have experience overseeing the establishment of biomarker assays at CROs.*A strong preference for a candidate with broad technical. Candidates with flow cytometry and molecular pathology (IHC, ISH) flow cytometry a plus.*Ability to work independently as well as collaboratively in a matrixed team environment.*Strong oral/written and interpersonal skills required*Ability to adjust priorities in a fast-paced environment.*Strong organizational and networking skills.*Strong oral/written English skills. 职能类别： 医药技术研发管理人员

联系方式

中山西路999号华闻大厦

公司信息

北海康成（北京）医药科技有限公司正式成立于2012年6月，总部设立在中关村望京科技创业园区内。 北海康成致力于解决满足“三个需求”，即满足中国患者对高效药物的需求、中国药企关键技术、产品更新换代的需求、发达国家中小生物制药企业进入中国市场的需求。 北海康成通过技术转让、吸收和再创新对接世界最大的生命高科技医药产品线与全球增长最快、潜力最大的应用市场。公司引进、研发、上市的重点是中国和亚洲市场所急需的特效药物。北海康成已经与欧美创新型生物制药公司、研究机构开展多个抗癌药物领域的技术合作。公司注重临床后期新药开发，有针对性地获取尖端的或国内新药研发所急需的制剂和生产工艺方面的成果，通过再创新和技术转化研发上市拥有自主知识产权的医药产品。

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上海相关职位： 专利工程师（生物药） 注册申报经理（生物药） 理化检验员 质量研究技术经理（活性检测） 工艺开发经理/副经理/高级专员/专员 临床项目助理 临床监察员 医学专员 中试生产高级专员/专员 制剂研究员

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企业入驻日期： 2017-11-09

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