DMPK Head

该职位来源于猎聘 Job Description: 1.主导自身免疫及炎症疾病领域多肽药物项目的DMPK策略制定与科研管理工作，统筹项目从候选化合物前期优化至IND申报全流程，融合药理、毒理学研究及药监合规要求推进项目落地。 Lead DMPK strategy and scientific management for peptide drug programs, with a strong focus on autoimmune and inflammatory disease indications, from pre-PCC optimization to IND submission, integrating pharmacology, toxicology and regulatory requirements. 2.搭建并优化PK/ADME技术平台，统筹体内外试验、LC-MS/MS生物分析、数据质控及GLP合规试验落地；联动内部团队及外部CRO合作资源，高效推进各项DMPK研发工作。 Establish and optimize PK/ADME platforms, oversee in vitro and in vivo studies, LC-MS/MS bioanalysis, data quality control and GLP-compliant execution. Actively coordinate and leverage both internal team resources and external CRO partners to support DMPK activities efficiently. 3.开展PK/PD、PBPK模型建模，完成人体药代预测及临床给药剂量推演，支撑候选化合物筛选及临床试验方案设计。 Perform PK/PD and PBPK modeling, human PK prediction and clinical dose projection to support candidate selection and clinical trial design. 4.联动药物化学、制剂、药理、毒理、CMC、注册等跨部门团队协同办公，保障研发项目高效推进。 Drive cross-functional collaboration with Medicinal Chemistry, Pharmaceutics, Pharmacology, Toxicology, CMC and Regulatory teams to ensure efficient project progression. 5.牵头DMPK研发风险评估、注册资料撰写及IND申报卷宗编制，全程符合国家药监局、美国FDA及ICH指导原则合规要求。 Lead DMPK risk assessment, regulatory documentation and IND dossier preparation, ensuring compliance with NMPA, FDA and ICH guidelines. 6.管理并培养内部DMPK团队人员（负责自研稳定性筛选、药代检测工作），标准化研发流程、提升团队专业能力，并行支撑多肽药物管线研发。 Lead and mentor internal DMPK team members (overseeing in-house stability screening and PK measurements), standardizing workflows and enhancing technical capabilities to support multiple peptide programs. 7.输出DMPK维度战略进展复盘及专业科研建议，助力公司研发管线优先级排布、项目投资决策研判。 Provide strategic DMPK updates and scientific recommendations to support pipeline prioritization and portfolio investment decisions. Qualifications 1.药代动力学、药物分析、药理学、生物学及相关专业博士学历；7年及以上药企DMPK从业经验，具备独立主导多肽药物中美双IND申报落地成功项目经验；拥有自身免疫类治疗药物研发实操经验。 Ph.D. in Pharmacokinetics, Pharmaceutical Analysis, Pharmacology, Biology, or related disciplines. Minimum 7 years of DMPK experience in the pharmaceutical industry, with a proven track record of successfully leading peptide drug programs through China/US dual IND filings. Hands-on experience with therapeutics for autoimmune diseases is required. 2.精通多肽类药物专属ADME特性、药代表征及生物分析策略；熟练掌握LC-MS/MS生物分析技术、体外ADME全套试验（蛋白水解稳定性、代谢稳定性、转运体抑制、药物相互作用、血浆蛋白结合、肝细胞孵育）及跨物种体内药代试验。 Strong expertise in peptide-specific ADME properties, PK characterization and bioanalytical strategies. Proficient in LC-MS/MS bioanalysis, in vitro ADME assays (proteolytic stability, metabolic stability, transporter inhibition, DDI, plasma protein binding and hepatocyte incubation), and cross-species in vivo PK studies.

• 可熟练使用Phoenix WinNonlin等定量药理建模平台，独立完成PK/PD建模、人体药代模拟及临床给药剂量预测工作。 Strong hands-on capabilities in PK/PD modeling, human PK simulation and clinical dose prediction using Phoenix WinNonlin or other quantitative pharmacology modeling platforms. 4.熟知多肽药物从前期候选化合物优化至IND全流程研发逻辑，精通DMPK、药理、毒理数据整合研判；熟悉GLP合规准则，可审核、复盘外部CRO出具的GLP合规试验报告。 Thorough understanding of peptide drug development from pre-PCC to IND, with solid knowledge of the integration of DMPK, pharmacology and toxicology data. Familiar with GLP requirements and capable of auditing/reviewing GLP-compliant study reports from external partners. 5. 熟知NMPA、FDA、EMA药监合规要求及对应ICH指导原则；具备IND申报DMPK板块撰写、审核及药监沟通对接实操经验。 Good knowledge of NMPA, FDA and EMA regulatory requirements and relevant ICH guidelines. Experience in preparing and reviewing DMPK sections of IND submissions and supporting regulatory interactions. 6.具备优秀团队管理及领导力，可搭建、培养DMPK团队，标准化作业流程、攻克研发技术难题；具备优异沟通能力、科研判断力及跨部门协同能力。 Strong leadership and people management skills, with the ability to build and mentor DMPK teams, standardize workflows and resolve technical challenges. Excellent communication, scientific judgment and cross-functional collaboration skills. 7.具备极强数据分析、报告撰写、申报卷宗审核能力；结果导向、责任心强，可在紧迫工期内统筹多项并行工作、合理排布工作优先级。 Strong analytical, report writing and dossier review capabilities. Results-oriented, highly accountable and able to prioritize multiple tasks under tight timelines. 8.英语口语读写流利，可适配国际办公协作。 Fluent English communication skills with the ability to work effectively in a global environment.