复星医药全球研发中心（中国）

复星医药中国全球研发中心的临床药理学（Clinical Pharmacology, CP）团队现招聘一名积极进取、富有动力的临床药理学家。岗位级别为首席科学家（Principal Scientist）至总监（Director），具体职级将根据候选人的经验和资历确定。CP团队负责为公司创新小分子药物及新型治疗技术平台（包括 siRNA 和 PROTAC 等）在药物研发全流程中提供临床药理学支持。
岗位职责
• 为临床开发项目提供临床药理学和定量药理支持，包括建立临床各阶段剂量依据（如 FIH剂量预测、II期剂量选择和III期剂量确认），并通过建模与模拟（M&S）和数据分析解析剂量—暴露—反应关系。
• 设计并负责实施专项临床药理研究（如食物影响、药物-药物相互作用、QT/cQT、质量平衡等），并参与注册申报资料的准备与答辩。
• 在首次人体研究PK及剂量预测、特殊人群剂量推荐及剂量优化等方面发挥关键作用。
• 主导或参与药物研发及注册相关文件撰写，包括沟通材料、临床试验方案、临床研究报告及注册申报资料。
• 与DMPK、毒理、生物统计、临床开发及注册事务团队等跨部门协作，推动项目顺利开展。

Global Research & Development Center – Fosun Pharma, China
The Clinical Pharmacology (CP) team in the Global Research & Development Center of Fosun Pharma China is seeking a highly motivated Clinical Pharmacologist, at the Principal Scientist to Director level, depending on the candidate’s experience.
The CP team provides clinical pharmacology support across all stages of drug development for innovative small molecules and emerging modalities, including siRNA and PROTACs.

DUTIES & RESPONSIBILITIES
Clinical Pharmacology Support
• Provide clinical pharmacology expertise to clinical development programs, including:
1. Develop dose rationale across all stages of clinical development, including FIH dose projection, Phase II dose selection, and Phase III dose confirmation.
2. Design and oversee dedicated clinical pharmacology studies (e.g., food effect, drug–drug interaction, QT/cQT, mass balance) in accordance with regulatory requirements.
3. Conduct data analyses and model-informed approaches (e.g., modeling and simulation) to characterize dose–exposure–response relationships and interpret results.
4. Contribute to the preparation and defense of regulatory submissions.
Quantitative Pharmacology & Modeling
• Provide quantitative pharmacology and modeling & simulation (M&S) support for clinical development projects.
• Play a central role in:
o Predicting PK and dose for first in human studies
o Characterizing dose–exposure–response relationships
o Justifying dose recommendations for special populations
Drug Development Documentation
• Lead or contribute to the preparation of drug development and regulatory documents, including: briefing document, clinical trial protocols, clinical study reports and regulatory submission packages
Cross-Functional Collaboration
• Collaborate with internal and external stakeholders to support assigned development programs.
• Work closely with related functions such as DMPK, toxicology, biostatistics, clinical, and regulatory teams.

任职要求
• 药学博士，专业方向包括DMPK、定量药理学、临床药理学等相关领域，或具备同等专业背景与经验。
• 3年以上临床药理或建模与模拟相关经验（行业或博士后），无行业经验者可根据资历考虑较初级职位。
• 具备早期或后期临床开发经验者优先。
• 熟练使用定量药理学学工具（如 NONMEM、R、Monolix 等），并对DMPK、毒理、生物统计、临床开发及注册科学有良好理解。
• 对工作有高度责任心和主动学习的意愿，有良好的跨部门沟通能力。

JOB REQUIREMENTS
• PhD or PharmD in relevant disciplines (e.g., DMPK, pharmacometrics, clinical pharmacology) or equivalent training and expertise.
• ≥3 years of relevant industry or postdoctoral experience in clinical pharmacology and modeling & simulation. Candidates without industry experience may be considered at a more junior title.
• Experience in early- and/or late-phase clinical development is desirable.
• Proficiency in pharmacometrics tools, such as NONMEM, R, Monolix, or similar platforms.
• Good understanding of related drug development disciplines, including DMPK, toxicology, biostatistics, clinical development, and regulatory science.
• Excellent communication and negotiation skills.
• Fluent in English, both written and spoken.
• Strong teamwork mindset with a high level of self-motivation.