本崗位可base全國任意分公司或homebase
崗位職責(zé):
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.
負(fù)責(zé)臨床試驗(yàn)項(xiàng)目臨床藥理板塊的業(yè)務(wù),進(jìn)行臨床藥理的數(shù)據(jù)進(jìn)行分析,可對(duì)甲方委托的臨床藥理業(yè)務(wù)進(jìn)行咨詢答復(fù)和專業(yè)知識(shí)的溝通;負(fù)責(zé)團(tuán)隊(duì)人員的搭建及維護(hù);協(xié)助BD進(jìn)行業(yè)務(wù)的推廣及拓展。
工作職責(zé) :
1.Responsible for participating in the project as the head of the clinical pharmacology section./
2.作為臨床藥理板塊負(fù)責(zé)人參與項(xiàng)目;
3.Responsible for participating in clinical trial design related processes and departmental SOP writing./
4.參與臨床試驗(yàn)設(shè)計(jì)相關(guān)流程及部門SOP撰寫;
5.Responsible for the collection and preliminary summary of preclinical and clinical related literature./
6.對(duì)臨床前、臨床相關(guān)文獻(xiàn)收集與初步總結(jié)進(jìn)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.負(fù)責(zé)對(duì)新藥早期臨床試驗(yàn)討論及早期研發(fā)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.負(fù)責(zé)完善臨床試驗(yàn)方案臨床藥理部分內(nèi)容撰寫、修訂及審核
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.負(fù)責(zé)臨床藥理學(xué)分析(PK/PD建模,E-R分析,劑量選擇,MB試驗(yàn)設(shè)計(jì),DDI試驗(yàn)設(shè)計(jì))支持臨床開發(fā)各階段策略制定;
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.負(fù)責(zé)對(duì)撰寫和審閱臨床藥理相關(guān)文件的復(fù)核,參與臨床試驗(yàn)設(shè)計(jì)相關(guān)流程及SOP撰寫和審核;
15.Responsible for supporting the communication of clinical pharmacology-related issues, data access and literature collation, and other work arranged by superiors./
16.支持臨床藥理相關(guān)問題的溝通,資料查閱及文獻(xiàn)整理,及上級(jí)安排的其他工作;
Job Requirements /崗位要求
1.Education Background/學(xué)歷背景 :Master degree or above in pharmacology, clinical pharmacology, pharmacokinetics or clinical pharmacy related fields./
藥理學(xué)、臨床藥理學(xué)、藥代動(dòng)力學(xué)或臨床藥學(xué)相關(guān)專業(yè)碩士及以上學(xué)歷。
2. Working Experience /工作經(jīng)驗(yàn) 7 years or more of work experience, related to clinical trials, clinical pharmacology, pharmacology and toxicology or pharmacokinetics is preferred
7年及以上工作經(jīng)驗(yàn),涉及臨床試驗(yàn)、臨床藥理、藥理毒理或藥代動(dòng)力學(xué)相關(guān)經(jīng)驗(yàn)優(yōu)先
3. Skills /能力要求 :Skilled at MS Office operation and Winnonlin./
熟練使用辦公軟件、winnonlin,CET-6 or above./英語六級(jí)及以上
任職要求:
1.Education Background/學(xué)歷背景 :Master degree or above in pharmacology, clinical pharmacology, pharmacokinetics or clinical pharmacy related fields./
藥理學(xué)、臨床藥理學(xué)、藥代動(dòng)力學(xué)或臨床藥學(xué)相關(guān)專業(yè)碩士及以上學(xué)歷。
2. Working Experience /工作經(jīng)驗(yàn) 7 years or more of work experience, related to clinical trials, clinical pharmacology, pharmacology and toxicology or pharmacokinetics is preferred
7年及以上工作經(jīng)驗(yàn),涉及臨床試驗(yàn)、臨床藥理、藥理毒理或藥代動(dòng)力學(xué)相關(guān)經(jīng)驗(yàn)優(yōu)先
3. Skills /能力要求 :Skilled at MS Office operation and Winnonlin./
熟練使用辦公軟件、winnonlin,CET-6 or above./英語六級(jí)及以上