PK药代动力学 工作职责
1. 负责各类型分子（小分子、ADC、单抗和多抗等）的不同阶段的（早期筛选、IND申报评估和临床阶段）非临床药代动力学研究。能够根据分子特征和不同阶段要求，设计关键性的药代动力学研究，选择有能力完成的CRO并与其密切合作，按时保质完成有关项目。
Be responsible for non-clinical pharmacokinetics studies of different molecular modality (small molecules, ADC, monoclonal antibodies, and polyclonal antibodies, etc.) at different stages (early screening, IND application evaluation, and clinical phase). Be able to design critical pharmacokinetics studies based on molecular characteristics and stage requirements, select capable CROs, and closely collaborate with them to complete relevant projects on time and with quality assurance.
2. 负责审核CRO开展的蛋白类大分子的PK/TK/ADA/Nab的生物分析（ELISA或MSD）方法，及化学类小分子的PK/TK生物分析（LC-MS/MS）方法，并能针对分子的特征和检测需求，指导CRO设计合适的检测方法，并能发现CRO试验中出现的问题且协调解决方案。同时具备ADC和小分子代谢物鉴定经验者更佳。
Be responsible for reviewing the biological analysis methods (ELISA or MSD) for protein macromolecules' PK/TK/ADA/Nab conducted by CRO, as well as the biological analysis methods (LC-MS/MS) for chemical small molecules' PK/TK. Additionally, able to guide CRO in designing appropriate detection methods based on the characteristics of the molecule and detection requirements, and capable of identifying problems in CRO experiments and coordinating solutions. Having experience in ADC and small molecule metabolite identification is a plus.
3. 会使用Winnonlin等药动学软件进行药动学参数计算，并根据参数解释分子的药动学特征。能够利用非临床和CMC的体内外数据，使用PBPK/POP-PK等定量药理学手段，建立相应药动学模型，来估算各种分子形式的人体药动学特征者更佳。
Be able to use pharmacokinetics software such as Winnonlin to calculate pharmacokinetic parameters and interpret the pharmacokinetic characteristics of molecules. It is preferable to be capable of utilizing in vivo and in vitro data from non-clinical and CMC studies, employing quantitative pharmacology methods such as PBPK/POP-PK to establish corresponding pharmacokinetic models for estimating the pharmacokinetic characteristics of various molecular forms in the human body.
4. 能根据药动学相关数据或结果，为上下游相关部门的候选分子质量标准和试验设计提供药动学相关建议。
Be able to provide pharmacokinetics-related recommendations for the quality standards and experimental design of the candidate to upstream and downstream related departments based on pharmacokinetics-related data.
5. 能够撰写药物申报文件M2.4、2.6、IB并与国内外监管部门沟通新药申报有关的非临床药动学问题。
Be able to draft drug application documents M2.4, 2.6, IB and communicate with domestic and international regulatory agencies regarding non-clinical pharmacokinetics issues related to new drug applications.
任职资格
1. 2年及以上的DMPK研究且有大分子生物分析或小分子生物分析经验；会使用Winnonlin等药动学软件；能根据非临床毒理、药代和药效剂量，以及体内外参数，初步预测临床剂量范围、人体PK特征、分子是否存在DDI等者优先。
Have 2 or more years of experience in DMPK research with expertise in large molecule or small molecule bioanalysis; proficiency in using pharmacokinetics software such as Winnonlin; preference given to those capable of preliminarily predicting clinical dosage range, human PK characteristics, and the potential for molecular DDI based on non-clinical toxicology, pharmacokinetics, pharmacodynamic dosage, and in vivo/in vitro parameters.
2. 药代动力学、药理学、生物分析等相关专业硕士（5年以上经验）或者博士（2年以上经验）
Have master's degree in pharmacokinetics, pharmacology, bioanalysis, or related fields (with over 5 years of experience) or a PhD (with over 2 years of experience).
3. 熟悉新药研发（尤其药动学、生物分析、毒理和定量药理等）的相关法律法规和指导原则，包括但不限于GLP、ICH指导原则。
Be familiar with the relevant laws, regulations, and guidelines for new drug development (especially pharmacokinetics, bioanalysis, toxicology, and quantitative pharmacology), including but not limited to GLP and ICH guidelines.
4. 具有良好的中英文写作能力和沟通协调能力以及团队合作精神。
Have good Chinese and English writing skills, communication and coordination abilities, as well as a spirit of team collaboration.
5. 积极主动、高效灵活的工作态度，以结果目的为导向、在有限的指导下能适应快速变化的工作环境。
Be proactive, efficient, and flexible work attitude, results-oriented, capable of adapting to a rapidly changing work background with limited guidance.