主要职能 Primary Function:
Zai Laboratory seeks individuals who can provide leadership and clinical expertise in NSI clinical research. Senior Medical Manager of Clinical Research will report to (Senior) Medical Director or other senior medical representative and work closely within cross functional study team and external collaborators to ensure optimal development program planning and execution.
主要职责 Major Responsibilities and Duties:
1) Provide medical expertise in the development of clinical research strategies to the NSI portfolio.
2) Under supervision of Senior Medical Representative to create global clinical development plans
in NSI TA, including the China development plan.
3) Act as NSI clinical research resource to the R&D department and contribute to project deliverables
4) At study level, provide medical expertise and leadership in driving the cross-functional collaboration in full cycle of study design, planning, conduct and closeout.
5) Provide diligent and vigilant medical monitoring at study level as well as project level to identify and act on any potential signal. Reviews and tracks emerging efficacy and safety data, keeps Senior Medical Representative informed of changes in the efficacy/ safety profile as they occur and takes action as appropriate.
6) Design efficient/ innovative clinical plans and clinical studies in close collaboration with clinical pharmacology, biostatisticians, regulatory affairs, other relevant disciplines, and KOLs. We place high value on efficiency, feasibility, most desirable labeling, and cost effectiveness.
7) Ensure high quality of study related documents of clinical study protocol, study report, manuscripts for publications and other relevant regulatory submission documents/ dossiers etc. When functioning as clinical monitor, this individual will prepare clinical study reports, regulatory dossiers, regulatory responses, review product labels, and prepare and review manuscripts for publication.
8) At project level, contribute to project development China strategy and where applicable proactively interact with external domestic as well as global partners to ensure the synergized development strategy and efforts.
9) Endeavor to think strategically, act decisively, work collaboratively, and drive performance to contribute to the company goals.
