Clinical Pharmacologist
Core
Define and execute China Clinical Pharmacology strategy to ensure late-phase study openings and successful NDA registration in China.
Role type
Senior Clinical Pharmacologist (China)
Builds
China-specific clinical development plans, regulatory submissions (CTA/NDA), and study protocols.
Domain
Biopharmaceuticals / Clinical Pharmacology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Pharmacology strategy, PK/PD analysis, Population PK, Exposure-Response analysis, Immunogenetics, QT analysis, Regulatory strategy (CDE), KOL management, Global collaboration
Preferred skills
Strategic thinking, MNC experience
Technologies
None stated
Responsibilities
Lead China CP strategy for late-phase studies and NDA; Represent China CP in global and local study teams; Review and contribute to CTA/NDA documents; Interpret CDE requirements; Manage local KOLs; Facilitate communication between China and global ASTs.
Seniority
Senior, hands-on IC