南平招聘

KEY ACCOUNTABILITIES:
-As CL (70%):
-Be capable of planning and directing a clinical program leading to regional regulatory submissions. This entails writing the clinical part of the Integrated Development Plan (IDP), protocol Extended Synopsis (ES), briefing package for meeting/consultation with HA, supervising the writing of the full study protocol, writing and/or directing Common Technical Document (CTD) clinical module, responces to HA inquries/deficiency letter in order to surely register the drug with appropriate scientific justifications.
-To coordinate and to supervise the conduct of clinical trials in compliance with Sanofi SOPs as well as institutional and governmental regulations and in close collaboration with the Clinical Study Director (CSD) and the Clinical Operations Group in order to ensure the completion of these trials with required quality and in a timely fashion. Supervise the writing of the Key Result Memo and of the Clinical Study Report.
-Serve as medical and scientific expert for the clinical programs and be responsible for the ongoing review of clinical trial data as regards to quality and in accordance with Asia Pacific regulations and ICH.
-Select, in collaboration with the Clinical Science & Operations platform, the investigator centers participating in these studies.
-Direct and take all responses – clinical part - in the building of AP registration dossier in close relationship with the Project Lead, Regulatory Affairs, and other key contributors.
-Interact with the Pharmacovigilance department to ensure that the serious adverse events occurring in clinical trials are followed up, evaluated, reported to regulatory authorities and notified to investigators promptly. Collaborate with Pharmacovigilance in the timely and accurate follow-up of the patient safety (e.g. adverse events) in clinical trials, ensure the data surveillance plan and the risk management plan, if any is implemented and conducted.
-Participate in written and oral presentations to experts and investigators, to business partners, and to regulatory bodies involving discussion of the clinical issues relating to the project.
-As PL (30%)
-Project Strategy:
Directs the creation of an IDP to translate the overall project strategy and scope into an executable development plan in AP region and countries. Leads the implementation of cross-functional Project Team at the start of a new project. Upon arrival of new team members, in collaboration with functional management trains the team member on project-specific issues and assures optimal integration into the team.
-Operational Management:
-Manage / coordinate the operational activities through a team approach in order to efficiently and diligently implement the development plan. Motivate and encourage team members with the goal of creating an ambitious, scientifically rigorous development team. In collaboration with the Operation Director, monitor, anticipate, and track any deviation from the agreed plan (time, risk, scope). Anticipate needs for a contingency plan and have such a contingency plan ready by the time the anticipated issue is faced. Work with team members and function heads to ensure the project is adequately resourced and all project milestones are completed as planned. Proactively identify potential issues and manage cross-functional and cross-cultural resolution.
-Drive project progression along the value chain through a team approach, in order to efficiently and diligently implement the development plan. Prepare, manage, and minute project team meetings on a regular basis. Organize and facilitate ad-hoc operational meetings, when needed. Co-Chair the CTD submission task force. Represent AP Development vis a vis Medical & Marketing, Pharma Operations and BUs (if any) in the AP region/countries, represent AP Development in the global Project Team as key member of this Project Team..Proactively identify potential issues and manage cross-functional resolution, as well as all cross-functional team activities including Business Unit/Division, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, and other key R&D departments , if applicable (e.g. CSO, CMC, DSAR).Ensure that team activities are in line with the overall timelines of the development plan in order to meet agreed project milestones.Foster trust, transparency, and cohesion within the team to ensure efficient communication channels with team members.Monitor resources required to complete activities as agreed, and work with each functional representative on the team to achieve this. Prepare project progression reports and present to management committees on regular project updates, milestone decision points, or on occasion of project deviations.
-In close collaboration with the Operation Director and team members, assume responsibility for the preparation and quality of the following documents, e.g. IIDP
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:
-CL:
-Use judgment and expertise in executing agreed strategy. Anticipate significant issues for discussion and resolution by clinical teams or management, as appropriate.
-PL:
-Authority to implement strategy as defined in approved IDP.
-Negotiate resource conflicts with functions.
-Implementation of strategic changes / addressing of emergent issues require close interaction with superior/appropriate management committees.
-Full director level: upon delegation by superior, assume leadership role in critical project-tasks, including key alliance interactions.
PARAMETERS FOR SUCCESS:
-Key Metrics
-Number of programs through phase transition, successful HA meeting, successful NDA approval.
-Organizational
-Network with internal stakeholders: Business Unit/Division, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, Medical and Marketing and other key R&D departments to provide direction for AP projects and clinical research activities within the therapeutic domain.
职位要求：
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
-Scientific degree (Ph.D.
M.D.
Pharm. D.).
-Certification in relevant medical or scientific specialties is a plus
-Other degrees may be acceptable as scientific qualification if supplemented by appropriate, documented on-the-job scientific expertise.
-Business degree / training (desired, but not necessary).
Experience & knowledge:
-7+ years in pharmaceutical industry
5+ years in global/clinical drug development (preferred)
3+ years in project management, as Project Manager (preferred). Strong medical background
-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
clinical development planning, clinical direction for NDA/BLA registration, 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 hematology, rare blood disorder or rare diseaseas 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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