- 5-7年经验
- 博士
- 招1人
- 12-30 发布
职位描述
Major Tasks & ResponsibilitiesThe Head PD Experts and his/her team are the dedicated clinical PD drivers for Bayer’s drug development portfolio in China in ensuring progression through key development milestones until and beyond market authorization and in LCM.Works closely with the Heads of Clinical Pharmacology and Experimental Medicine in Clinical Sciences (CS) as well as with the Therapeutic Area (TA) representatives in Clinical Development, Regulatory Affairs, Pharmacovigilance, and the respective Strategic Marketing groups to optimize the output and value of clinical drug development in China.Ensures a centre of expertise in clinical pharmacodynamics, medical aspects and relevant indications/ therapeutic areas.Builds and leads a highly qualified team of Clinical PD / Medical Experts, including 3rd parties. The PD / Medical Experts are in charge of developing clinical PD strategies for each project in clinical development in close alignment with the respective CSCR, Clinical Pharmacology / Experimental Medicine Lead, China Project Team, Global Program Leader and Global Clinical Leader.Responsible as physician (medical officer) for all medical aspects of drug candidates in the CSC development program, reviews/approves the medical / pharmacodynamic activities and decisions of the PD / Medical Experts of the PD Experts China group.Reviews/approves the clinical PD / medical content of the assigned study protocols as all other clinical documents or the respective clinical sections, e.g. in investigator brochures (IBs), clinical study reports, publications, IND/CTA or NDA submissions.Representing CSC externally, e.g. in meetings with authorities, ethics committees and key opinion leader meetings. Networking with in-house and external experts as well as key opinion leaders, academic institutions and contract research organizations.Providing medical as well as clinical pharmacological advice and expertise to design, plan, execution and evaluation of clinical pharmacological studies conducted in China and other Asian countries.Participating in specialist conferences, seminars/relevant educational events and taking into account the state of scientific knowledge and publications, local and international authority guidelines / requirements and in-house regulations (e.g. SOPs)Providing medical and clinical pharmacology expertise in due diligences of potential in-licensing projects and in out-licensing activitiesClosely collaborate with global CS functions such as Clinical Pharmacology, Biomarker, Pharmacometrics, Operations and Experimental Medicine, as well as functions outside CS, e.g. GPT, GRS, and GPV etc.He/she may also act as a PD Expert, Clinical Sciences China Representative (CSCR) or Clinical Pharmacology Leader (CPL) for assigned projects within global project teams and related clinical subteams. Please refer to the relevant Job Descriptions for details. 职能类别: 医药技术研发管理人员
联系方式
东三环北路27号嘉铭中心A座
公司信息
拜耳医药保健是拜耳集团的子集团,是世界十大医药企业之一,也是医药保健及医疗产品行业世界领先的创新企业之一,全球拥有员工53100人,总部位于德国的勒沃库森。拜耳医药保健致力于研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品。2008年,拜耳医药保健全球销售额达154.07亿欧元,其中研发经费为17.42亿欧元,占拜耳集团总研发投入的66%。 拜耳医药保健和中国的渊源可以追溯到20世纪初期。早在1936年,拜耳就在中国成立第一个生产公司-拜耳医药公司,生产一系列产品。目前,拜耳医药保健有限公司在中国拥有员工约4000人,总部位于北京。在北京、广州、成都、江苏设有工厂,致力于拜耳先灵医药、保健消费品、糖尿病保健及动物保健四大业务。其中,拜耳先灵医药是拜耳医药保健有限公司下属最大业务部门,是拜耳医药保健的处方药部和先灵(广州)药业有限公司合并而成,业务遍及70多个城市,产品线覆盖普药业务、女性健康、特殊治疗以及影像诊断四个领域。2008年7月,拜耳医药保健的保健消费品部收购了东盛盖天力西药非处方药业务。 2008年,拜耳医药保健完成了投资达2.2亿余元人民币的北京生产厂的扩建。 北京工厂新建的生产线将采用目前中国乃至亚洲地区最为先进的设备,产能是以前的4倍。除了硬件系统投资,拜耳医药保健北京工厂还引入先进的软件管理系统,包括全自动称重系统、物流管理系统等将使得药品的品质更上一层楼。 拜耳医药保健有限公司在中国的发展蒸蒸日上。 在业务发展的同时,拜耳医药保健始终不忘社会责任,积极与社会各方面进行深入合作。2008年11月,与中国就业促进会合作开展了“农业富余劳动力健康安全转移就业培训项目”,计划在3年内对3万名农业富余劳动力免费提供健康安全转移就业培训。尽管目前处在全球经济困难期,我们仍将继续关注那些需要帮助的社会弱势人群。 为促进并提高中西部地区县级医院的整体医疗服务技术水平,2008年拜耳医药保健和卫生部合作的“走进西部”万名县级医院医师培训项目成功开展。目前已在甘肃、青海、宁夏、云南四省进行了6期培训工作,已有363人参加了培训。2009年“走进西部”项目还将延伸到江西、广西、陕西、贵州、新疆等五个省份,共计划培训1122名医生。 2009年初,拜耳医药保健新的研发中心将在北京落户,成为其全球架构中的第四大研发中心。这一举措不仅表明了我们在中国长期发展的决心和信心,并为拜耳医药保健成为亚洲制药领域的领导者提供坚实基础。
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