Regional Director of Clinical Development
职位描述
Specific accountabilities:
- Designing a clinical strategy plan in line with the overall strategy defined by R&D, the country (China)/regional and the International Regulatory and marketing needs
- Gaining approval of this clinical-regulatory strategy plan from the relevant committees of sanofi pasteur
- Leading the local(China) and/or the regional clinical teams in the execution of the assigned clinical studies:
- Leading the clinical team composed of various functions (e.g. study monitoring, data management, biostatics, medical writing, Pharmacovigilance among others) and in charge of all operational aspects for the purpose of developing, implementing and executing the study. The RDCD, when acting as CTL, leads the clinical team members, ensures adequate participation, contribution and accountability of the study team members and ensures adherence to the relevant SOP Processes.
- Working in close collaboration with the Clinical Operations Managers for planning, assigning resources and controlling the budget by ensuring that this budget and resources appropriately meet the needs of the study, while maintaining cost controls.
-Ensuring that all clinical trial activities in China and/the region comply with the highest quality and ethical standards and that strict confidentiality is maintained
- Defining, in close collaboration with Pharmacovigilance, the safety surveillance process and risk management plan
- Leading the writing of clinical documents (protocols and reports) in line with the defined clinical-regulatory strategy
- Leading the interpretation and critical evaluation of study results and ensuring reporting of results from the clinical studies (including presenting results in scientific meetings or congresses)
- Participating in all registration activities including the preparation of clinical part for the Common Technical Document
- Building an effective network with internal and external teams (opinion leaders, investigators and relevant agencies).
- Designing a clinical strategy plan in line with the overall strategy defined by R&D, the country (China)/regional and the International Regulatory and marketing needs
- Gaining approval of this clinical-regulatory strategy plan from the relevant committees of sanofi pasteur
- Leading the local(China) and/or the regional clinical teams in the execution of the assigned clinical studies:
- Leading the clinical team composed of various functions (e.g. study monitoring, data management, biostatics, medical writing, Pharmacovigilance among others) and in charge of all operational aspects for the purpose of developing, implementing and executing the study. The RDCD, when acting as CTL, leads the clinical team members, ensures adequate participation, contribution and accountability of the study team members and ensures adherence to the relevant SOP Processes.
- Working in close collaboration with the Clinical Operations Managers for planning, assigning resources and controlling the budget by ensuring that this budget and resources appropriately meet the needs of the study, while maintaining cost controls.
- Ensuring that all clinical trial activities in China and/the region comply with the highest quality and ethical standards and that strict confidentiality is maintained
- Defining, in close collaboration with Pharmacovigilance, the safety surveillance process and risk management plan
- Leading the writing of clinical documents (protocols and reports) in line with the defined clinical-regulatory strategy
- Leading the interpretation and critical evaluation of study results and ensuring reporting of results from the clinical studies (including presenting results in scientific meetings or congresses)
- Participating in all registration activities including the preparation of clinical part for the Common Technical Document
- Building an effective network with internal and external teams (opinion leaders, investigators and relevant agencies).
职位要求:
Requirement:
- MD or equivalent degree as Doctor of medicine required.
- Experience of clinical research, in the Pharma industry, including design, management and implementation of international clinical development programs
- Experience with vaccines, infectious diseases or related fields will be a plus
- Scientific and analytic skills
- Ability to develop a global approach
- Strong network ability
- Excellent presentation and communication skills
- Good organizational and project management skills
- Team leader, impact & influence
- Autonomy
- Team player, ability to work within a matrix organization
- High levels of drive, initiative and commitment
- Fluent in written and oral English and Chinese (Mandarin)
企业简介
赛诺菲集团是一家全球领先的多元化医药健康企业,专注于患者需求,传播健康。全球100,000余名员工,业务遍及100个国家,新兴市场实力均衡,表现强劲,位列第一,多元领域,覆盖处方药、健康药业产品、疫苗和动物保健品,疫苗领域的领导者
领先动物保健市场,2011年集团净销售额达334亿欧元
赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团,也是国内增长最快的医药健康企业之一。目前,赛诺菲在中国200多个城市拥有6000余名员工。
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年,赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天,赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海,并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。
独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗,赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年,杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月,赛诺菲完成了对BMP太阳石的收购。
大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地,包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。
完善的研发架构、双赢的研发合作模式
在中国,赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心,并在北京和成都分别设有研发机构。自2008年以来,赛诺菲与中国权威科研机构开展了10多项战略合作,在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物
依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源,公司在中国的市场份额不断攀升,公司规模不断扩大,飞速发展的业务给了我们与更多优秀人才合作的机会。
如需了解更多信息,请访问www.sanofi.cn
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北京相关职位: 医药信息代表(儿童肥胖DSM)
热门区域招聘: 重庆 北京 上海 浙江 江苏 广东 山东 湖南 安徽 河北
北京招聘企业: 叮当智慧药房(北京)有限公司 北京久峰润达生物技术有限公司 北京协和医院 北京海斯美医药技术有限公司 北京策知易咨询有限公司 北京万泰生物药业有限公司 百济神州 北京凯霖娜国际贸易有限公司好益生医院分公司 中国生物制药有限公司 国药集团工业有限公司
职位发布日期: 2019-04-01