高级医学专员（临床药理方向）

岗位职责: 1.参与创新药物早期临床研究方案设计，从临床药理学角度提供起始剂量、剂量递增、给药途径、给药频率、DLT观察期及剂量调整等设计建议； 2.结合药物作用机制、非临床药效/毒理数据、同类产品开发经验及监管要求，支持剂量选择和给药方案的科学论证； 3.参与PK/PD、暴露-反应、药物互相作用、食物影响、免疫原性、生物标志物、细胞动力学等相关研究内容设计，包括采样时间点、检测指标和分析思路； 4.支持研究方案、研究者手册、临床药理学说明、监管沟通材料等文件中临床药理相关内容的撰写、审阅与修订； 5.与医学、统计、数据管理、临床运营、药物警戒及外部专家团队协作，参与项目关键设计问题讨论，并提供清晰、可执行的专业建议。 1.Participate in the design of early-phase clinical trial protocols for innovative therapeutics by providing clinical pharmacology recommendations on starting dose, dose escalation, route of administration, dosing frequency, dose-limiting toxicity (DLT) observation period, and dose modification strategies. 2.Support scientific justification for dose selection and dosing regimens by integrating the mechanism of action, nonclinical pharmacology and toxicology data, development experience from comparable products, and applicable regulatory requirements. 3.Contribute to the design of PK/PD, exposure-response, drug-drug interaction, food effect, immunogenicity, biomarker, and cellular kinetics assessments, including sampling schedules, study endpoints, and analytical approaches. 4.Draft, review, and revise clinical pharmacology-related sections of study protocols, Investigator’s Brochures, clinical pharmacology summaries, regulatory briefing materials, and other study documents. 5.Collaborate with cross-functional teams, including Medical Affairs, Biostatistics, Data Management, Clinical Operations, Pharmacovigilance, and external experts, to provide clear, practical clinical pharmacology recommendations for key study design decisions. 任职资格: 1.临床药理学、药理学、药代动力学、药学、临床医学等相关专业硕士及以上学历，博士优先； 2.具备3年以上创新药早期临床开发、临床药理或药代/定量药理相关工作经验，有I期/FIH项目经验者优先； 3.熟悉早期临床试验设计，能够支持剂量选择、给药方案、PK/PD采样及安全性监测策略设计； 4.具备PK/PD、暴露-反应、群体PK或剂量模拟等相关知识，有CGT或其他新型治疗产品开发经验者优先； 5.具备良好的科学判断力、逻辑表达能力和跨团队沟通能力，能够独立支持项目讨论与方案设计。 1.Master’s degree or above in Clinical Pharmacology, Pharmacology, Pharmacokinetics, Pharmacy, Clinical Medicine, or a related discipline; PhD preferred. 2.At least 3 years of experience in early clinical development, clinical pharmacology, pharmacokinetics, or quantitative pharmacology for innovative therapeutics. Experience with Phase I/FIH studies is preferred. 3.Familiarity with early-phase clinical trial design, including dose selection, dosing regimen development, PK/PD sampling strategies, and safety monitoring plans. 4.Solid understanding of PK/PD, exposure-response relationships, population pharmacokinetics, or dose optimization approaches. Experience in CGTs or other advanced therapeutic modalities is preferred. 5.Strong scientific judgment, analytical thinking, and cross-functional communication skills, with the ability to independently support protocol development and project discussions.