Job objectives
• development of innovative products stemming from Pyrotech’s internal research and development activities, from lead candidate selection to regulatory submissions and approvals.
负责管理由Pyrotech内部研发活动产生的创新产品非临床开发工作，涵盖从先导候选化合物筛选至监管申报与审批通过的全流程
• Coordinate all nonclinical activities, such as toxicology, safety pharmacology, bioanalysis and DMPK, to ensure optimal project progress during the project lifespan.
统筹协调毒理学研究、安全药理学评估、生物分析及DMPK（药物代谢与药代动力学）等非临床研究活动，确保项目在全生命周期内的高效推进
• 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)
保障非临床研究交付成果与文件资料的及时性及合规性，满足临床试验申请、监管机构沟通及全球市场注册要求（包括研究者手册IB、研发期间安全性更新报告DSUR、年度报告AR、预审评会议资料pre-IND、临床试验申请IND/CTA及新药上市申请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.
定期向内部相关项目团队汇报非临床研究进展，主导与CRO（合同研究组织）等外部合作伙伴的沟通协作，推动非临床研究执行
Key Requirements:
• Advanced degree in pharmacology, toxicology or a related biological science
具有药理学、毒理学或相关学科硕士以上学位
• A minimum of 3 years working experience in nonclinical drug development within the biopharmaceutical industry
具备至少3年在生物医药行业非临床药物开发方面的工作经验
• Deep understanding of CDE, FDA and international regulatory requirements and guidelines (ICH, EMA) related to nonclinical safety pharmacology and toxicology
对CDE、FDA和国际注册的要求以及非临床安全药理学和毒理学相关的指导方针(ICH、EMA)有较深入的理解
• Excellent communication and collaboration skills, which will enable effective interactions with internal teams and external collaborators
具备优秀的沟通和协作技能，确保与内部团队和外部合作者的有效互动与合作
• Fluent in English reading and writing, and highly proficient in spoken English.
英语读写流利，口语熟练