职位详情
临床药理经理/总监 可homebase
2-4万
凯莱英医药集团(天津)股份有限公司
广州
不限
硕士
10-28
工作地址

科林源创新大楼-A座越秀区先烈中路100-67号5楼501

职位描述
本岗位可base全国任意分公司或homebase
岗位职责:
概述 :Responsible for the business of the clinical pharmacology section of the clinical trial project, analyze the clinical pharmacology data, and communicate the consultation reply and professional knowledge of the clinical pharmacology business entrusted by sponsor;Responsible for the construction and maintenance of team personnel, assist BD in business promotion and expansion.
负责临床试验项目临床药理板块的业务,进行临床药理的数据进行分析,可对甲方委托的临床药理业务进行咨询答复和专业知识的沟通;负责团队人员的搭建及维护;协助BD进行业务的推广及拓展。
工作职责 :
1.Responsible for participating in the project as the head of the clinical pharmacology section./
2.作为临床药理板块负责人参与项目;
3.Responsible for participating in clinical trial design related processes and departmental SOP writing./
4.参与临床试验设计相关流程及部门SOP撰写;
5.Responsible for the collection and preliminary summary of preclinical and clinical related literature./
6.对临床前、临床相关文献收集与初步总结进行分析
7.Responsible for the discussion of early clinical trials of new drugs and the formulation and update of early research and development strategies./
8.负责对新药早期临床试验讨论及早期研发策略制定及更新
9.Responsible for improving the clinical pharmacology part of the clinical trial plan writing, revision and review./
10.负责完善临床试验方案临床药理部分内容撰写、修订及审核
11.Responsible for clinical pharmacological analysis (PK/PD modeling, E-R analysis, dose selection, MB study design, DDI study design) to support the development of strategies at all stages of clinical development./
12.负责临床药理学分析(PK/PD建模,E-R分析,剂量选择,MB试验设计,DDI试验设计)支持临床开发各阶段策略制定;
13.Responsible for the review of the writing and review of clinical pharmacology-related documents, participate in the clinical trial design related processes and SOP writing and review./
14.负责对撰写和审阅临床药理相关文件的复核,参与临床试验设计相关流程及SOP撰写和审核;
15.Responsible for supporting the communication of clinical pharmacology-related issues, data access and literature collation, and other work arranged by superiors./
16.支持临床药理相关问题的沟通,资料查阅及文献整理,及上级安排的其他工作;
Job Requirements /岗位要求
1.Education Background/学历背景 :Master degree or above in pharmacology, clinical pharmacology, pharmacokinetics or clinical pharmacy related fields./
药理学、临床药理学、药代动力学或临床药学相关专业硕士及以上学历。
2. Working Experience /工作经验 7 years or more of work experience, related to clinical trials, clinical pharmacology, pharmacology and toxicology or pharmacokinetics is preferred
7年及以上工作经验,涉及临床试验、临床药理、药理毒理或药代动力学相关经验优先
3. Skills /能力要求 :Skilled at MS Office operation and Winnonlin./
熟练使用办公软件、winnonlin,CET-6 or above./英语六级及以上
任职要求:
1.Education Background/学历背景 :Master degree or above in pharmacology, clinical pharmacology, pharmacokinetics or clinical pharmacy related fields./
药理学、临床药理学、药代动力学或临床药学相关专业硕士及以上学历。
2. Working Experience /工作经验 7 years or more of work experience, related to clinical trials, clinical pharmacology, pharmacology and toxicology or pharmacokinetics is preferred
7年及以上工作经验,涉及临床试验、临床药理、药理毒理或药代动力学相关经验优先
3. Skills /能力要求 :Skilled at MS Office operation and Winnonlin./
熟练使用办公软件、winnonlin,CET-6 or above./英语六级及以上

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