Responsibilities：
职责：
? Maintain a current understanding of PK, PD and toxicology literature and methodology. Get understanding of the latest status of competitors in the market to guide candidate product development.
关注药理学、药代动力学和毒理学研究方法和技术的新进展，了解同靶点药物的最新研发状态指导候选产品的开发。
? Design and manage non-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions following latest regulatory requirements, including pharmacology, pharmacokinetics and toxicology.
依照相关法规的最新要求，设计和管理非临床研究(GLP和非GLP)，包括药理学、药代动力学和毒理学研究，以支持注册申报。
? Oversees CROs in the design, conduct, analysis, trouble shooting, documentation and data retention, and interpretation of PK, PD and toxicology studies, and conduct on-site inspections to ensure that studies are delivered within agreed quality, cost and timeline parameters.
监管CRO开展药理药代和毒理学研究，包括方案设计和实施、疑难问题解决、数据分析和阐释，原始记录及文件归档等； 现场核查，以确保CRO的研究在规定时间和预算内达到预期的质量要求。
? Review non-clinical study reports to ensure accurate reflection of study data and scientific interpretation of study results.
审核非临床研究报告，确保如实反映实验数据，并对结果进行科学阐释。
? Prepare and edit non-clinical documents for regulatory submission and regular updates for life-cycle management.
准备和撰写注册及产品生命周期维护相关的非临床文件。
? Work closely with other functions to support the candidate selection, CMC process changes, clinical protocol development, annual report and RA submissions.
与公司其他各部门紧密合作，支持候选分子筛选、药学工艺调整、临床方案设计、年度报告更新、注册文件准备等工作。
? Other work as requested.
按要求完成其他工作。
Qualifications：
要求：
? M.S. scientist with 3+ years of industry experience. Background in pharmacology, toxicology, pharmacokinetics or related fields.
有3年以上工业界工作经验的硕士。药理、毒理，药代等相关背景。
? Familiar with regulatory guidelines and experience in IND-enabling studies.
熟悉新药研发相关法规并从事过支持新药申报的研究。
? Experience in CRO would be a plus.
有乙方经验者更佳。
? Literature and database retrieval, reading and analysis ability in English.
具备英文文献检索，阅读和总结能力。
? Proven capability in independent trouble-shooting.
具备独立处理、解决问题的能力。
? Highly flexible, and team player who enjoys working in a fast-paced dynamic environment.
高度灵活性，具有团队合作能力，能适应快节奏的环境。
（工作地点：北京）