Lead the clinical development for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds).
Deeply understand global clinical development strategy and plan. Lead cross-functional team to development and drive CD plan, and ensure the clinical development plan fully aligned for China and globally (for some specific China R&D driven compounds). Keep the China clinical development plan updated. Be responsible for the clinical project planning.
Propose clinical study design and develop clinical study protocol based on the clinical development plan, Be accountable for all clinical deliverables (e.g. clinical study reports and submission summary / HA response document) if applicable. Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Act as compound medical physician for some specific China R&D-driven compounds. Provide physician guidance and expertise on patient care to clinical studies (including medical monitor, etc).
Provide clinical input for commercial assessment and portfolio prioritization. Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders. Undertake tasks as agreed with the TA head.
Train and develop team if applicable. Provide hands-on coaching and guidance to team members identify talent and create talent development and retention plan and ensure the plan is well executed.
在中国设立常用药品事业部、抗感染药品事业部、中枢神经药品事业部和肿瘤药品事业部,实施区域化管理,建立了极具竞争力的产品组合。公司在心血管、内分泌、抗感染、肿瘤、骨代谢、中枢神经系统等10大领域拥有20多种国际一流的高科技专利产品。
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