Job objectives ? development of innovative products stemming from Pyrotech’s internal research and development activities, from lead candidate selection to regulatory submissions and approvals. 負責管理由Pyrotech內部研發活動產生的創新產品非臨床開發工作，涵蓋從先導候選化合物篩選至監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. 統籌協調毒理學研究、安全藥理學評估、生物分析及DMPK（藥物代謝與藥代動力學）等非臨床研究活動，確保項目在全生命周期內的高效推進 ? 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性，滿足臨床試驗申請、監管機構溝通及全球市場注冊要求（包括研究者手冊IB、研發期間安全性更新報告DSUR、年度報告AR、預審評會議資料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. 定期向內部相關項目團隊匯報非臨床研究進展，主導與CRO（合同研究組織）等外部合作伙伴的溝通協作，推動非臨床研究執行 Key Requirements: ? Advanced degree in pharmacology, toxicology or a related biological science 具有藥理學、毒理學或相關學科碩士以上學位 ? A minimum of 3 years working experience in nonclinical drug development within the biopharmaceutical industry 具備至少3年在生物醫藥行業非臨床藥物開發方面的工作經驗 ? 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和毒理學相關的指導方針(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 具備優秀的溝通和協作技能，確保與內部團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