南平招聘

KEY ACCOUNTABILITIES:
-Clinical Research Leadership:
-Be capable of planning and directing a clinical program leading to regional regulatory submissions. This entails writing the clinical part of the AP part of the IDP (integrated development plan), and writing (be the author of) the protocol Extended Synopsis (ES) of the study/ies.
-To provide guidance and assist in the conduct of clinical trial programs in the AP region in collaboration with the Clinical Study Director (CSD) and the Clinical Operations Group (CSO).
-Serve as medical and scientific expert for the clinical programs, including:
-Identify and working with key KOLs and sites in the disease area
-The final review of clinical trial data as regards to accuracy, quality.
-The collaboration, together with the CSD, with the Pharmacovigilance department in the timely and accurate follow-up of the patient safety (e.g. adverse events) in clinical trials, and the data surveillance plan and the risk management plan, if any is implemented and conducted.
-The participation in building and review of the Key Result Memo and of the Clinical Study Report.
-Cooperate and participate – clinical part - in the building and writing of AP registration dossier in close relationship with the AP Project Lead(if separate role), Regulatory Affairs, and other key contributors.
-Participate in written and oral presentations to experts and investigators, to business partners, to development management and to regulatory bodies involving discussion of the clinical issues relating to the project.
-As Project Lead
-Project Strategy:
-Directs the creation of an AP Integrated Development Plan (IDP) to translate the overall project strategy into an executable development plan.
-Leads the implementation of tailored cross-functional Project Team.
-Operational Management:
-.Manage the Projcet team in order to efficiently and diligently implement the development plan. In collaboration with the Project Manager, monitor, anticipate, and track any deviation from the agreed plan (time, risk, scope). Anticipate risks and if needed contingency planning. Proactively identify potential issues and manage cross-functional and cross-cultural resolution..
-Co-Chair the CTD submission task force.
-Represent AP Development and vis a vis Medical & Marketing, Pharma Operations and BUs in the AP region/countries, represent AP Development in the Global Project Team. Proactively identify potential issues and manage cross-functional resolution, as well as all cross-functional team activities.
-In close collaboration with the Project Manager and team members, assume responsibility for the preparation and quality of the following documents, e.g. AP part of the Integrated development plan (AP –IDP), Presentation to Management Board, including Position Papers
Project Team Objectives
Executive Summaries and minutes/actions of Project Team meetings. Supervise the completion of clinical overview, clinical-regulatory documents (such as investigator’s brochure, benefit/risk assessment, briefing package for health authorities, etc..). Full director level: proven ability to independently develop above mentioned documents up to a quality ready for management sign-off.
DECISION RIGHTS:
-Project Lead:
-Authority to implement strategy as defined in IDP.
-Negotiate resource conflicts with functions.
-Implementation of strategic changes / addressing of emergent issues require close interaction with manager/appropriate management committees.
-Full director level: upon delegation by management, assume leadership role in critical project-tasks, including key alliance interactions.
-Clinical leadership:
-Use judgment and expertise in executing agreed strategy. Anticipate significant issues for discussion and resolution by clinical teams or management, as appropriate.
PARAMETERS FOR SUCCESS:
-Key Metrics
-Number of programs through phase transition. NDA submission & approval.
-Organizational
-Network with internal stakeholders: Therapeutic Area Development Lead, AP Development Head and Global Project Head, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, medical and Marketing, BUs and other key R&D departments to provide direction for AP projects and clinical research activities.
职位要求：
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
-Scientific degree (Ph.D.
M.D.
Pharm. D.). MD degree is required for the clinical lead position, prior clinical position as a phycisian is a plus. Certification in relevant medical or scientific specialities is a plus
-Other degrees may be acceptable as scientific qualification if supplemented by appropriate, documented on-the-job scientific expertise.
Experience & knowledge:
-5+ years in pharmaceutical industry
3+ years in global/clinical drug development and or equvalent clinical trial expereince
Strong medical background. Ideally with experience in other industry medical functions (medical affairs, clinical operations, safety or translational medicine)
-People / Team Management skills:
Ability to lead and challenge multifunctional teams
conflict resolution, and ability to facilitate decision-making
ability to conduct effective meetings
ability to work effectively in cross-cultural environments.
-Technical Competencies in areas such as: Drug development including experience with clinical projects
project management
scientific knowledge and experience
budget management
resource management
-Operational Competencies: Performance-oriented, and achievement-oriented, audacious
familiar with details of drug development process
analytical and troubleshooting competencies
creativity and common sense
issue and conflict analysis
able to communicate and negotiate across all levels of organization
ability to operate in an international and cross-functional environment
professionalism and demonstrates solidarity with organization and team members
customer focus
interpersonal savvy with respect for people
good communication skills (written and oral).
-More specifically from Clinical Research view point:
-strong medical background particularly in Immunology-Inflammation and/or rhumatology area as well as a very good understanding of the drug development process and the regulatory framework for clinical trials.
-The ability to interpret clinical data accurately is essential.
-Strong verbal and written communication skills in English and local language (such as Chinese, Japanese, etc) are required to complement the ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions.
-Good knowledge and experience with the process of data collection, management, and analysis are required for direct and indirect management of this process.
-Good negotiation and persuasion skills are important.

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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