长沙招聘

Support and advice Development and Research Teams in Asia Pacific Region on pharmacokinetics, PK-PD and drug disposition. Work with Medical and Industrial affairs for bioequivalence studies and with Business Development for due diligence activities. Help develop the most appropriate clinical strategies with these teams, present PK strategies for FIH and Population PK plans for Phase III studies. Responsible for PK analysis for the projects. Develop the PK part of the dossier, write protocols, evaluate CRO and collaborator data and be responsible for PK parts of audits. Provide technical expertise to project teams, partners and CROs as required. Work with teams to use and develop innovative PBPK models that improve PK predictions.
The incumbent will report directly to the Head of PKDM AP. All administrative and scientific management oversight will be directly supported by PKDM AP head.
Duties and Responsibilities
-Be an integral part of Clinical Development project teams, drive projects forward with innovative PKDM approaches that meet team goals.
-Contribute to projects by conducting or interpreting PK or PK-PD analysis, so that studies are conducted at the correct dose range in China and other Asian countries, as required. Interpret and communicate data to teams, with an assessment of impact on strategy, including proposals for issue resolution, as required.
-Work closely with project and global teams to provide appropriate, effective and timely responses to all queries from CFDA or other regulators in the region.
-Work with Outsourcing team to provide expertise for large and small molecule PK evaluations Interface with central labs and CROs, as required. Provide support for CRO selection, audits, monitor studies and review reports.
-Support Unit due diligence efforts and help identify opportunities derived from these evaluations for future PKDM innovation.
-Be a champion for PKDM in the region and actively participate in utilizing and building PBPK models relevant to Sanofi projects.
-Provide expertise to Unit supporting precandidate drug discovery for evaluation of small molecules and biologics for ADME (absorption, distribution, metabolism and excretion) properties. Collaborate with external and internal partners on study design, evaluate and present data, write and review reports.
-Develop and maintain knowledge within PKDM of present and future Unit needs and champion shared ownership for collective success between PKDM and Unit.
职位要求：
Knowledge and Skill Requirements
Education/Training:
-A PhD in a relevant scientific field, including pharmacokinetics, drug metabolism or chemistry.
-Eight to fifteen years’ experience in the pharmaceutical industry, with a focus on metabolism and pharmacokinetics-related project support.
-A clear understanding of drug metabolism and pharmacokinetics.
-Must be able to conduct pharmacokinetic evaluations and the ability to use PBPK models would be a plus.
-Experience with working in global matrix teams.
-A good understanding of Regulatory guidance relevant to PKDM. These include CFDA, FDA and EMA guidance.
-Ability to effectively communicate, verbally and in writing, in English and Chinese.
Knowledge & Skills:
-Expertise in pharmacokinetics, drug metabolism and PK/PD analysis in a drug development environment.
-Knowledge of pharmacokinetics – relevant Regulatory guidances, particularly from the CFDA.
-Well organized, able to communicate clearly, and represent the project and team needs appropriately.
-Good team player, demonstrated ability to work in matrix teams, willing to participate in late evening teleconferences and travel as required.

赛诺菲集团
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***
 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。

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