长沙招聘

JOB PURPOSE:

This position is in Translational Medicine & Clinical Pharmacology, the global department functioning across all of the therapeutic areas at Sanofi with a scope that includes performing early development clinical trials for small molecules, biologics, and other therapeutic modalities. This department is part of the TMED (Translational Medicine and Early Development) group in R&D Development. The individual works with global project teams on clinical development for compounds in Asia, as well as with local teams to execute the development strategy, conduct clinical studies, and support regulatory interactions.  A key aspect of this position is medical and scientific supervision and management of clinical trials performed by the Translational Medicine & Clinical Pharmacology group.  Development of biomarker and translational medicine plans and clinical trial design are also important elements of the position.  The individual functions as the study medical manager for Phase 1 to 2 clinical studies that are related to projects in clinical development and for marketed drugs.  Collaborative interactions with pharmacokineticists, laboratory research scientists, toxicologists, modeling and simulation experts, biomarker experts, and therapeutic area clinicians are critical to success in the role. 

The individual will provide support to the global project team by providing expertise on clinical development in Asia, as well as local support to regulatory interactions. 

SUPERVISED RESOURCES:

No subordinates

KEY ACCOUNTABILITIES:

• Significantly contribute to the Asia strategy of global product development by providing expertise on early clinical development requirements in Asia, especially any country-specific requirements
• Provide medical and scientific management for a clinical study (from study design to final study report), including coordination of the clinical study team to set up and follow the study, and ensure correct conduct of the study
• Develop a regulatory strategy for studies/compounds (in conjunction with regulatory colleagues) and interact with local teams to support regulatory requirements and interactions
• Design safe, scientifically sound clinical studies, including the biomarker and translational medicine plan
• Work closely with pharmacokineticists on clinical study design and strategy
• Review and approve study documentation (case report forms, monitoring plan, statistical analysis plan, contracts, documents for Ethics Committees/Health Authorities, etc.)
• Prepare and/or approve documents related to the study and requiring scientific/medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators, etc.)
• Provide medical training and serve as medical contact to study team, CSUs (Medical Advisors, monitoring, etc.) and investigators
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects. 
• Review and interpret results, including safety data, Serious Adverse Event reports, and data review and validation meetings before database lock
• Author translational medicine and clinical pharmacology-related clinical documentation, including clinical protocols, key results memo, clinical study reports; abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents, etc.
• Ensure an adequate follow-up of studies and project timelines. 
• Present data in appropriate meetings (inside or outside the Group).
• Support the CSUs and affiliates to develop a network of KOLs and experts and to select National Coordinators or members of Study Committees
• Serve as medical contact for inspections or audits of Phase 1/2 clinical trials in China
• Provide expertise on medical and clinical pharmacology questions from Health Authorities to support regulatory interactions, IRB/Ethics Committees, investigators, external experts

• Major Challenges and opportunities:

• Communication of the role of the department; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative attitude.
• Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic, and proactive person.
• Ensure clinical trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.
• Ensure high quality documents, requiring strong writing and communication skills.
• Manage aggressive timelines effectively through cross-functional planning.

• Key Internal/External Relationships:

• Internal contacts: Pharmacokineticists, Clinical Trial Operations team (including clinical trial managers, data managers, feasibility managers), Clinical Study Team, Project Leader, Biostatistics, Preclinical Safety, Regulatory Affairs, Global Pharmacovigilance, Therapeutic Area Research and Development Groups, CSUs.
• External contacts: Investigators, early phase clinical research organizations, clinical trial vendors, clinical and scientific experts, ethics committees, health authority representatives.

• Decision Making Authority:

  Makes front-line decisions on protocol design, execution, dose escalation and safety, medical advice and input for any medical matter of the study/project, clinical pharmacology/translational medicine input for local development strategy, and information for regulatory authorities.

  
  

  
  

  JOB-HOLDER ENTRY REQUIREMENTS:

  
  

  Language skills:

• Fluent in English (writing and speaking)

• Education:

• Advanced degree: M.D. or M.D./Ph.D., or PharmD or Ph.D degree in a health-related science
• At least 2 years of experience in conducting clinical trials and clinical pharmacology
• At least 2 years of experience in early drug development
• At least 2 years of  experience with interactions with regulatory agencies for early drug development

• 
  

  Experience & knowledge:

• Experience with the conduct of clinical trials 
• Qualification in a medical specialization is preferred
• Experience in clinical pharmacology and early development clinical trials is preferred
• Experience in pharmacokinetics is preferred
• Previous experience in Clinical Research and/or Drug Development and/or Pharmacovigilance
• Previous experience in translational medicine is preferred
• Knowledge in ICH, GCP, and local regulations

• 
  

  Core competencies:

• Knowledge and mindset in early clinical development and translational research
• Able to acquire and apply new technical skills
• Scientifically inquisitive
• Excellent communication skills
• Committed and enthusiastic person with a positive, collaborative attitude

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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