长沙招聘

The Clinical Scientist Team Lead leads locally a team of Clinical scientists and coordinate with other local teams, under the supervision of Global Lead, to support the Clinical Study Director in the medical supervision and scientific management of all clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) Medical Operations (MO) of Sanofi R&D.
He/She builds and organizes a group of clinical scientists.
He/She selects and manages senior profiles with strong expertise in clinical operations.
Foster a true, business minded, partner-oriented, atmosphere and skill set for the group.
Develop a true Team building spirit within the group and Team members.
Develop and facilitate interaction and partnership with representatives other Units departments.
He/She can play a role of Senior Clinical Scientist.
Main Responsibilities
1.Management of operations
Ensure scientific support for operational realization within the CSO for study(ies) or registries he/she is allocated to under the functional supervision of the CSD and/or Medical Operations management, by securing the operationalization of the medical validation/review plan (reports and trackers).
Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of decreasing the complexity.
For all new protocols, is in charge of calculating the protocol complexity index, before and after protocol review, and after any protocol amendment.
Is involved in the medical review of study data under the CSD supervision, support the CSD for the medical review of data with the manual reconciliation of the case by case review of safety events reported to GPE or safety events of special interest, listings.
Help for the preparation, organization and minutes of study Committees, follow the contracts with business support.
Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (extended synopsis, protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form ?. Participates to the CTT and monitoring team training on medical information.
Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct.
Support CSD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project.
Support CSD in organizing Steering committees, Data Monitoring Committees, Adjudication Committee meetings.
develop study specific training material for training to Medical advisors and sites.
Propose and develop in coordination with CSD and CTOM/DM study specific medical data points checks based on protocol efficacy criteria.
With CTOM track and follow-up on missing data related to these criteria
Support CSD, define precisely the critical data, and implement/develop related sections of the study risk management plan.
Coordinate medical validation/review activity with CME and GSO from GPE, notably to anticipate and prevent last minute queries or backlog, and smooth the process.
2.Management of organization
Evaluate resources and workload, allocate Clinical Scientists to provide support for projects/studies, in close collaboration with the other local teams
Align on priorities, evaluate performance, career and training needs for his/her team in accordance with industry trends and regulation, and in the context of the departmental orientations.
3.Quality/Process improvement
Continually evaluate processes and tools for improvements. Participate in working groups to develop and implement new processes and procedures. Maintain knowledge of current regulations and technologies. Participate in the implementation of department transversal initiatives.
Promote and develop use of electronic tools (A/J review, e-PP) in the context of medical review /validation
Develop good quality management practices, including guidelines, as regard to medical review/validation activities.
职位要求：
Required Knowledge And SkillsLeadership and management skills
Ability to build constructive and effective relationships, demonstrates flexibility and diplomacy
Be an inspiring role model for his/her team, motivates team
Set clear assignments, objectives and measures
monitor process, progress and results
Scientific expertise or interest and ability to learn in the domain of assigned study/project.
High level of autonomy and motivation
Quality focused and well organized
Strong communication skills (verbal and written)
Ability to handle multiple tasks and to prioritize
Ability to synthesize the information, good presentation skills
Excellent decision-making and problem-solving capabilities
Capability to challenge decision and status quo
Ability to work autonomously and to efficiently & effectively provide status reports
Ability to anticipate and timely escalate issues and to define appropriate action plans
Leam and results oriented
Teaching skills, ability to assist and train others
Strong English skills (verbal and written if English is the second language)Required Education/Experience:
MD, Ph.D., Pharm.D., or similar
bachelor degree considered for candidates with experience.
Previous experience in Clinical Research and/or Clinical Drug Development (e.g., at least 10 years within pharma industry or CRO).
Knowledge in ICH, GCP.Fluent in English.

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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