主要职能 Primary Function:
Zai Laboratory seeks individuals who can provide leadership and clinical expertise in Dermatology and Immunology clinical research. He/she will report to senior medical lead ([Sr] Medical director or other senior medical representatives) and work closely with clinical operation, regulatory, clinical pharmacology, biostats and other development functions, as well as external scientific advisors to ensure optimal development program planning and execution.
主要职责 Major Responsibilities and Duties:
85 Provide medical expertise in the development of clinical research strategies to the NSI portfolio.
85 Under supervision of Senior Medical Representative to create global clinical development plans in NSI TA, including the China development plan.
85 Act as NSI clinical research resource to the R&D department and contribute to project deliverables.
85 Design efficient/ innovative 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.
85 Ensure high quality clinical study protocols, study reports and other relevant regulatory submission documents/ dossiers. 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.
85 At study level, provide medical expertise and leadership in driving the cross-functional collaboration in full cycle of study design, planning, conduct and closeout.
85 Provide diligent and vigilant medical monitoring at study level as well as project level to identify and act on any potential signal.
85 Reviews and tracks emerging efficacy and safety data, keeps senior medical lead informed of changes in the efficacy/ safety profile as they occur and takes action as appropriate.
85 Engage scientific leaders (KOLs) and regulatory authorities to develop suitable clinical plan and protocol.
职位要求：
85 A MD or MD/PhD, desired with postgraduate training in Immunology/dermatology/respiratory or other TAs that may fulfill the projects’ need.
85 At least 2 years’ experience of clinical work in a public hospital.
85 At least 5 years’ experience of clinical research with track records of developing strategy, protocol and study report writing, successful execution of strategy.
85 The candidate who is ideally suited for this position should be bright, driven, dedicated, persistent, strategic, flexible, and clever.
85 The candidate should have leadership and written and oral communication skills.