Responsibilities

• 1、Clinical Pharmacology Strategy Planning: Develop strategies and implementation plans for pharmacokinetics (PK), pharmacodynamics (PD), drug-drug interactions (DDI) and related studies in clinical stages; define research priorities and core pathways based on drug characteristics.
• 2、Study Protocol Design & Review: Lead or participate in the design of PK/PD, bioequivalence and other clinical trial protocols; review protocol amendments and related documents to ensure compliance with ICH, NMPA, FDA, EMA and other regulations and clinical research standards.
• 3、Data Management & Interpretation: Coordinate the collection, organization and analysis of clinical pharmacology data; guide or collaborate in building PK/PD models and deeply interpret data; evaluate PK profiles, efficacy and safety in special populations and patients with concomitant medications, supporting dose adjustment and regimen optimization.
• 4、Regulatory Communication & Registration Support: Assist in communication with NMPA, FDA and other regulatory agencies on clinical pharmacology issues; participate in drafting and reviewing clinical pharmacology sections of CTD documents and IND/NDA dossiers to ensure compliance and completeness.
• 5、Cross-functional Collaboration: Liaise with clinical operations, medical affairs, pharmacovigilance, regulatory affairs and other departments to align research progress and resolve issues, ensuring smooth project execution.
• 6、Technology Innovation & Industry Tracking: Continuously monitor regulatory updates, technical advances and research hotspots in clinical pharmacology; evaluate the value of population PK, pharmacometrics and other new technologies; promote optimization and innovation of research methods.

Requirements

• 1、Education: Master’s degree or above, PhD preferred, in clinical pharmacology, pharmacology, pharmaceutical sciences, medicine or related fields.
• 2、Experience: ≥8 years of clinical research experience in pharma industry, with at least 4-5 years focused on clinical pharmacology; experience in innovative drug development from Phase I to III, and participation in ≥2 successfully approved or late-stage drug projects preferred.
• 3、Technical Competence: Proficient in clinical pharmacology theories and methods; skilled in PK/PD modeling, DDI assessment, PK studies in special populations; deep understanding of ICH (E8, E10, E14, etc.), NMPA, FDA, EMA guidelines; ability to independently design protocols, interpret complex data and solve key technical problems; proficient in Phoenix WinNonlin, NONMEM, etc.
• 4、Soft Skills: Strong cross-functional communication and negotiation skills; rigorous, responsible, able to work under pressure; sharp problem-solving and decision-making abilities; proficient in English (reading/writing/speaking) for regulatory documents, reports and international communication.