临床药理研究

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 3-4年工作经验 | 硕士

2022-11-11发布

招聘人数:3人

100000-300000元/年

申请职位

职位信息

Position Summary You will be responsible for data analysis and result interpretation of clinical studies. You may also work with experienced team member to contribute to a study design, data analysis plan development, TLF (Table, Listing, Figure) design, and result report as well. Position Responsibility - Work independently or collaboratively with experienced team member in clinical pharmacology supporting ongoing projects. - Perform or assist with PK/PD analyses including modeling and simulation for understanding of the PK/PD relationship of drug candidates. - Review and QC analysis results and outputs for other team members. - Ensure working process following good practice of study requirement and SOPs. - Participate in ongoing group meetings and project team meetings including data analysis, slide preparation for study updates and identified issues. - Be exposed to various other functions within the clinical pharmacology. Requirements - Master degree in pharmacokinetics, pharmaceutical sciences, or related discipline; Ph.D. or Pharm.D. will be a plus - Hands-on experience in PK / PD analysis, or clinical pharmacology or related experience - Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines - Solid knowledge of pharmacokinetic principle and drug development process - Must be proficient with at least one PK analysis software such as Phoenix WinNonlin, NONMEM etc. - Ability to interpret analysis results and impact on the study medication - Familiar with ICH/GCP guidelines, and FDA, EMA, and CFDA guidance - Proficient in spoken and written English 备注: ‘职位年薪’ 仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
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