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临床药理经理

面议

上海市

刷新时间:2023-01-09

职位描述

岗位描述:
主要职责 Main responsibilities:
1. 对新药申报(IND、 NDA)提供临床药理学支持,包括与监管机构的沟通。
To provide clinical pharmacology support to the submissions for new drugs (IND, NDA), including the communication with authorities.
2. 对一期、二期以及三期研究设计、方案、统计分析报告、临床报告等提供临床药理学支持。
To provide clinical pharmacology support to the study design and preparation for protocol, SAP, SAR, CSR etc.,
3. 与药政、生物分析部门、临床运营团队、生物统计与数据管理团队、临床医学团队进行密切合作。
To closely collaborate with regulatory, bioanalysis, clinical operation team, biostatistics and data management team, clinical medical science team.
4. 运用定量药理学软件,对药动学、药效学数据进行分析,为公司决策以及在各个国家的产品申请和注册提供定量药理学支持。
To provide pharmacometrics support for the decision of company strategy, and the submission in worldwide countries through using pharmacometrics tools to analyze PK and PD data.
5. 与第三方合作,针对定量药理学服务进行沟通与监督。
To communicate with and supervise 3rd party vendors providing pharmacometrics service.
6. 负责出版物的临床药理学内容。
To be responsible for the clinical pharmacology related sections in the publications.
7. 对内部提供产品相关的临床药理学培训。
To provide internal clinical pharmacology training related to products.
任职条件 Competency and qualification
1. 教育要求:研究生学历,药理学、药动学硕士及以上
Education requirements:Graduate degree, master degree or above of pharmacology, pharmacokinetics
2. 工作经验要求:硕士,5年及以上临床药理、临床试验相关工作经验;博士,2年及以上临床药理、临床试验相关工作经验; 具有定量药理学实际操作经验(POPPK, PK/PD分析)
Work experience requirements: Master degree, 5 yrs or above work experience related to clinical pharmacology, clinical trial; PhD degree, 2 yrs or above work experience related to clinical pharmacology, clinical trial; hands on experience on pharmacometrics (POPPK, PK/PD analysis)
3. 知识与技能要求:
Knowledge and skills requirements:
1) 熟悉临床试验,理解临床试验中的生物统计学。
Be familiar with clinical trials and understand the biostatistics in clinical trials.
2) 熟悉中国、欧盟、美国的药政、临床试验相关的政策法规及技术指导原则。
Be familiar with clinical trial related regulatory requirements and technical guidelines from CFDA, EMA, and FDA.
3) 熟悉办公软件。
Be familiar with Office tools.
4) 较强英文文献阅读能力,以及一定的英文撰写能力,能流利进行英语交流者优先。
To have strong ability of reading English articles and materials; ability of English writing, fluent English communication is preferred.
5) 能够使用NONMEM, WinNonlin。
To have capability of using NONMEM, WinNonlin.
6) 对生物分析(小分子、大分子)有一定了解; 有实际操作经验以及方法学建立验证经验者优先。
To have certain understanding of bioanalysis (small molecular and large molecular); having hands on experience of bioanalysis and methods validation is preferred.
7) 有较强的学习能力,可以学习新的工具(SAS,R等),希望在建模与拟合领域进一步发展。
To have strong capability of learning new technology and tools (SAS, R etc.,); be expecting to furtherly develop in modeling and simulation.
4. 品性要求:
Personality requirements:
1) 具有良好的团队合作精神、良好的沟通能力。
To have good teamwork spirit and communication capability.
2) 具有严谨的科学精神
To have rigorous science attitude.
3) 面对挑战,具有较强的抗压能力
To have strong stress tolerance facing challenging.
关键考核指标 Key performance indicators
1. 按时提供高质量的临床药理相关分析报告。
To provide clinical pharmacology related analysis reports of high quality on time.
2. 为临床试验相关、注册相关的材料文档按时提供高质量的临床药理相关内容。
To provide clinical pharmacology related sections of high quality for clinical trials and submission related documents and materials on time.
3. 保持与公司内部各个职能的良好沟通与紧密合作,及时给予专业建议,确保项目顺利进行。
To keep good communication and close collaboration with internal functions and provide professional suggestions in time to ensure the projects going on smoothly.
4. 对外部供应商进行有效的监督和指导,确保供应商提供高质量的临床药理相关的服务。
To superise external vendors effectively and provide guide to ensure the vendors can provide clinical pharmacology delivery of high quality.
5. 保持与药政机构审评专家以及外部专家的良好沟通,更好的支持公司的项目。
To keep good communication with regulatory authority reviewers external experts to support company’s projects.

其他要求

  • 100人
  • 药理/毒理/药效

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
分公司总

企业信息

名称:
诗迈医药猎头
行业:
制药.生物
性质:
私营/民营企业
规模:
100-499人

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