Shanghai Research & Development
Nonclinical Scientist
ShanghaiFull timeCNY 25K-30K / month
Posted:
Generate and evaluate the pharmacokinetic and toxicology evidence used in drug development and submissions. Your work will span literature review, study design and execution, external research oversight, and the documentation of findings—with responsibility for scientific quality and timely delivery.
What you’ll do
- Conduct pharmacokinetic and toxicology studies for drug development and submissions: review the literature, design and carry out experiments, and analyze and evaluate the results.
- Select qualified external partners for part or all of a study. Assess the scientific soundness of their plans, oversee the research, and review and accept deliverables, ensuring quality and timely completion.
- Coordinate, write or review the toxicology and pharmacokinetic documentation for nonclinical studies.
What you’ll bring
- A master’s degree or higher in pharmacology, toxicology, pharmacokinetics or a related discipline.
- Two to six years of work experience, including at least two years in pharmacokinetics and toxicology.
- Experience managing or preparing submissions for at least three PCC or IND projects.
- Knowledge of toxicology and pharmacokinetic guidance and regulatory requirements, with the corresponding in vivo experimental skills.
Preferred experience
- Experience writing research documentation in English.
- Experience analyzing biological samples.
Original posting · Chinese
非临床科学家
岗位职责
1、负责新药研究开发和申报过程中药代动力学和毒理实验，包括文献调研、实验设计和执行，实验结果分析和评价； 2、筛选有资质的第三方参与、支持项目全部或部分研究活动，把控方案科学性，并对第三方研究过程进行监督、对研究成果进行审评验收、保障质量与进度； 3、统筹、撰写或审核非临床研究毒理和药代相关资料； 4、上级主管交代的其他工作；
任职要求
1、药理学、毒理学、药代动力学等相关专业，硕士以上学历； 2、2~6年工作经验，需2年以上药代毒理相关工作经验，需有3个以上PCC或IND项目管理或申报经验，有英文资料撰写经验加分； 3、掌握毒理学和药代动力学相关指导原则和监管要求；掌握毒理学和药代动力学相关的体内实验技能；有生物样本分析经验优先；