1. 根據(jù)中心總體規(guī)劃目標(biāo),組建方案開發(fā)與方法學(xué)平臺(tái),并組織開展業(yè)務(wù)工作; 2. 負(fù)責(zé)組織制定中心方案開發(fā)與生物統(tǒng)計(jì)業(yè)務(wù)工作制度、規(guī)章、操作標(biāo)準(zhǔn)等規(guī)范,并監(jiān)督實(shí)施; 3. 組織對(duì)部門人員進(jìn)行專業(yè)培訓(xùn)、指導(dǎo)與考核,參與部門人員招聘; 4. 負(fù)責(zé)組織部門開展與臨床試驗(yàn)項(xiàng)目方案開發(fā)、統(tǒng)計(jì)分析工作,并在計(jì)劃時(shí)間內(nèi)高質(zhì)量地完成; 5. 負(fù)責(zé)組織建立、維護(hù)與相關(guān)專業(yè)領(lǐng)域?qū)<业牧己藐P(guān)系,就方案開發(fā)與統(tǒng)計(jì)分析中遇到的專業(yè)問題與專家進(jìn)行溝通咨詢; 6. 負(fù)責(zé)就部門業(yè)務(wù)與中心其他相關(guān)部門進(jìn)行溝通和協(xié)調(diào),組織部門對(duì)中心其他部門提供及時(shí)、高效的技術(shù)支持; 7. 完成上級(jí)交辦的其他工作。 1. Establish and manage the program development and methodology platform. 2. Develop and implement regulatory and operational standards for program development and bio-statistics. 3. Lead training, recruitment, and assessment of departmental personnel. 4. Oversee clinical trial protocol development and statistical analysis. 5. Maintain relationships with industry experts to address complex project issues.
任職要求
1. 專業(yè)經(jīng)驗(yàn):具有在生物醫(yī)藥或CRO行業(yè)10年項(xiàng)目開發(fā)或方法學(xué)平臺(tái)工作經(jīng)驗(yàn),3年部門管理的工作經(jīng)驗(yàn),精通臨床試驗(yàn)設(shè)計(jì); 2. 領(lǐng)導(dǎo)能力:具有出色的領(lǐng)導(dǎo)和執(zhí)行力,以及優(yōu)秀的溝通、培訓(xùn)和演講技能; 3. 教育背景:醫(yī)學(xué)或藥學(xué)博士學(xué)歷; 4. 政策法規(guī):熟悉國(guó)內(nèi)國(guó)際藥械監(jiān)管的法律法規(guī)和產(chǎn)業(yè)政策; 5. 行業(yè)視野:熟悉國(guó)內(nèi)外藥物研究發(fā)展和現(xiàn)狀; 6. 語言能力:具備在英語環(huán)境下勝任崗位職責(zé)的能力; 7. 特別優(yōu)秀者,可適當(dāng)放寬任職條件。 1. 10+ years of experience in project development or methodology within the bio-pharmaceutical or CRO industry. 2. Strong leadership and execution skills, with excellent communication and presentation abilities. 3. PhD in Medicine or Pharmacy. 4. Familiar with domestic and international regulations governing drug and device development. 5. Fluent in English with the ability to perform duties in an English-speaking environment. 6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.