岗位职责：

• This position will be responsible for all aspects of clinical pharmacology and biopharmaceutics studies in China by close collaboration with global QCP. This individual will be able to take the project lead to generate study designs, protocols, review/proofreading and author reports and co-author primary and secondary sections of regulatory documents in China.  
• The individual will be able to take global study QCP lead role to design, develop and implement and monitor execution of strategies to advance clinical development.
• The individual will be capable of establishing and be proficient in performing modeling and simulation analysis etc. for both projects in China and global.
• The scientist is expected to join China working group meeting as QCP China rep to provide insights & inputs for new study evaluation/ PK strategy for IND submission/ PK analysis plan for BLA submission /Dossier preparation/CDE’s query response etc.
• The scientist will join global QCP working group meeting to provide insights to global QCP strategy at project level as China regional rep
• Work independantly with minimum supervision with China cross functional team (i.e., Biostats and programmer team) and global QCP to develop appropriate China-specific TFL/report and author the submission dosser to support China submission
• Work with the global team to understand the Clinical Pharmacology strategy and then independently Interface with China regulatory agencies to communicate with accurate data/documents and be capable of independently present Clinpharm outcome and address China health authority’s queries related to Clinpharm.
• Lead clinical pharmacology feasibility assessments for Business Development external assets/opportunities
• Participates in KOL interactions at project level and works independently for all phases of studies
• Review/proofreading documents including protocol/ICF/HGRAC/submission dossier etc.
• Interface with Clinical Study Lead and Outsourcing to develop and manage project budgets for sites, contract research organizations (CROs) and other vendors independently; Manage CRO contacts and other vendors as needed for China alone studies.

资历要求：

1. Master degree and above (PhD preferred) majored in Pharmacology, Pharmaceutical sciences or clinical pharmacology
2. 10 or More Years with a MS degree, 3 or More Years with PhD
3. Fluent English listening, speaking, reading and writing skills. Added value: Japanese
4. Strong communication skills
5. Excellent ability to multitask
6. Skilled Microsoft and AI capability