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Job objectives
? development of innovative products stemming from Pyrotech’s internal research and development activities, from lead candidate selection to regulatory submissions and approvals.
負(fù)責(zé)管理由Pyrotech內(nèi)部研發(fā)活動產(chǎn)生的創(chuàng)新產(chǎn)品非臨床開發(fā)工作，涵蓋從先導(dǎo)候選化合物篩選至監(jiān)管申報與審批通過的全流程
? Coordinate all nonclinical activities, such as toxicology, safety pharmacology, bioanalysis and DMPK, to ensure optimal project progress during the project lifespan.
統(tǒng)籌協(xié)調(diào)毒理學(xué)研究、安全藥理學(xué)評估、生物分析及DMPK（藥物代謝與藥代動力學(xué)）等非臨床研究活動，確保項目在全生命周期內(nèi)的高效推進(jìn)
? Ensure timely and adequate nonclinical deliveries and documentation for clinical trial applications, regulatory interactions, and market registrations to global regulatory authorities (including IBs, DSURs, ARs, pre-INDs, INDs/CDAs and NDAs)
保障非臨床研究交付成果與文件資料的及時性及合規(guī)性，滿足臨床試驗申請、監(jiān)管機(jī)構(gòu)溝通及全球市場注冊要求（包括研究者手冊IB、研發(fā)期間安全性更新報告DSUR、年度報告AR、預(yù)審評會議資料pre-IND、臨床試驗申請IND/CTA及新藥上市申請NDA等）
? Provide regular updates to internal stakeholders/project teams on the progress of nonclinical activities and lead interactions with external partners, including CROs to execute nonclinical studies.
定期向內(nèi)部相關(guān)項目團(tuán)隊匯報非臨床研究進(jìn)展，主導(dǎo)與CRO（合同研究組織）等外部合作伙伴的溝通協(xié)作，推動非臨床研究執(zhí)行
Key Requirements:
? Advanced degree in pharmacology, toxicology or a related biological science
具有藥理學(xué)、毒理學(xué)或相關(guān)學(xué)科碩士以上學(xué)位
? A minimum of 3 years working experience in nonclinical drug development within the biopharmaceutical industry
具備至少3年在生物醫(yī)藥行業(yè)非臨床藥物開發(fā)方面的工作經(jīng)驗
? Deep understanding of CDE, FDA and international regulatory requirements and guidelines (ICH, EMA) related to nonclinical safety pharmacology and toxicology
對CDE、FDA和國際注冊的要求以及非臨床安全藥理學(xué)和毒理學(xué)相關(guān)的指導(dǎo)方針(ICH、EMA)有較深入的理解
? Excellent communication and collaboration skills, which will enable effective interactions with internal teams and external collaborators
具備優(yōu)秀的溝通和協(xié)作技能，確保與內(nèi)部團(tuán)隊和外部合作者的有效互動與合作
? Fluent in English reading and writing, and highly proficient in spoken English.
英語讀寫流利，口語熟練