Senior PK Expert招聘_拜耳医药保健有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Purpose:The Senior Pharmacokinetics Expert (Sr. PK Expert) of TMO China will independently provide PK knowledge and expertise for all phases of development projects and the related clinical development studies. He/she ensures adequate consideration of all aspects of the PK/pharmacodynamics (PK/PD) relationship of development compounds. He/she will independently plan and supervise the PK aspects of clinical studies of assigned development projects, including but not limited to China Phase 1 studies and China involvement of the global Phase 3 registration studies.Sr. PK expert of TMO China will serve as China representative to China Project Teams (CPTs) to provide early development strategies for clinical development and product registration in China. He/she will utilize regional knowledge and expertise with the goal of optimizing decisions to advance products to regulatory approval globally, with special focus on Chinese requirements, with a competitive and state-of-the-art product label.The position holder may act as clinical pharmacology lead (CPL) or PK expert within global project teams and related clinical sub-teams. As CPL he/she will independently lead, direct and coordinate the TMO team to complete all globally relevant TMO activities during clinical development and to provide adequate Clinical Pharmacology input into phase 1, 2 and 3 as well as LCM studies in a time- and resource-efficient manner.A Sr. PK expert at CSC may supervise, coach, or mentor other PK experts.Tasks:Independently representing TMO China in Global Project Teams (GPTs) and China Project Teams (CPTs) to provide China early development strategy to global and China development programs.When appointed as Clinical Pharmacology Leader (CPL ), representing global TMO function in GPTs and related clinical teams. Independently creating, updating and implementing the Clinical Sciences Development Plan (generally after D6) or contributing to it (generally until D6) and presenting it to decision-making committees within the company. Responsible for coordination of all TMO activities related to preparation and submission of dossiers (NDA).Providing in-depth PK and/or Clinical Pharmacology advice and expertise to independently design, plan, execute and evaluate appointed trials in close collaboration with the study teams. Independently inspecting, evaluating and reporting new results within the context of development projects.Actively 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)Independently responsible for content and timely provision of clinical pharmacological documents such as IB, IMPD, study protocols, PSUR/DSUR contributions, study reports, IND, and NDA documents as well as publications, when appointed as CPL. Independently providing PK contributions to these documents when appointed to a project or individual studies. Additionally for China studies, contributing to the translation verification of protocols, CSRs, briefing documents, and other CS-related documents supporting China CTA/NDA filings.Representing TMO externally, e.g. in meetings with authorities or key opinion leaders. Networking with in-house and external experts as well as key opinion leaders, academic institutions and contract research organizations. Managing interdisciplinary cooperation with in-house and external project partners.Value added:The Sr. PK Expert ensures that PK aspects are adequately addressed during the entire clinical development program including post-approval activities. A particular focus lies on the PK/PD relationship and on ensuring that the relevant questions are addressed adequately with state-of-the-art technologies and expertise.As CPL, design and drive all global CS activities during drug development to create a state-of-the-art drug label, to reduce business risk, to increase portfolio value as well as to trigger major investments at each milestone during the development program.He/she independently represents the company in meetings with authorities and within the scientific community. He/she is a well-recognized contact partner for external collaborations with academic institutions and/or contract research organizations.Work relationships:The Sr. PK Expert when representing TMO China on CPTs will closely interact with other functional representatives from project management, regulatory affairs, country medical experts, biostatistics, clinical operations etc . He/she may be assigned to GPTs to provide early input on China development options for early stage projects before a CPT is formed.The Sr. PK Expert when representing Clinical Sciences as CPL in global project teams is the key driver of the clinical pharmacology program in early as well in late clinical development. He/she is closely interacting with all functions represented in the global project team and the related clinical team and is furthermore providing a feedback loop on the respective experiences. 职能类别：生物工程/生物制药

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。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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