Specific Responsibilities： 1.This position will be functionally part of the Quantitative Clinical Pharmacology (QCP) function in support of our drug development and commercialization activities in China. 2.This position will be responsible for the Clinical Pharmacology plans and deliverables for China by close collaboration with global QCP. This individual will be able to support or take a lead to generate study designs, protocols, review/proofreading and author reports and co-author primary and secondary sections of regulatory documents in China, in collaboration with the global QCP Global Project Team representative. 3.The scientist is expected to identify, generate and execute study protocols with external CROs, and collaborate with and represent QCP at global functional teams as needed including Clinical Development and Operations, Project Management, Bioanalytical and Drug Metabolism to design, develop and implement and monitor execution of strategies and short and long term experiments to advance clinical development. 4.The scientist is expected to join China cross functional team 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. 5.Interface with Clinical Study Lead and Outsourcing to develop and manage project budgets for sites, contract research organizations (CROs) and other vendors; Manage CRO contacts and other vendors as needed. 6.Interface with China regulatory agencies representing the QCP function which includingbut not limited to: reEnsure scientifically accurate translation/proofreading of global documents and communications withChina regulatory agencies toanswer questions related toClinical Pharmacology and Clinical Bioanalytical matters. 7.Interface with Study Lead and QCP GPT representative to develop and manage study timelines and track study milestones to support China submissions. 8.Coordinate activities within a multi-functional team to execute study protocols per timeline and budget. 9.Coordinate with CRO to review and provide input as needed to the following documents: Study Protocol, Statistical Analysis Plan and Clinical Study Report. 10.Work with CROs and Daiichi Sankyo Data Management to develop appropriate China-specific data collection documents including Case Report forms (CRFs), diaries, questionnaires, and completion manuals (or provide input to development of electronic CRFs and other supporting electronic documents). 11.Review/proofreading documents including protocol/ICF/HGRAC/submission dossier etc. 12.Coordinate and/or conduct pre-study (including CRO/Lab kick-off meeting), initiation and interim monitoring visits; generate, review and/or approve trip reports as appropriate.
Qualifications： 1.PhD 2.Minimum 5 years of industry experience 3.Required: Chinese, English；Added value: Japanese
