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Top 制药外资 Clinical Research Physician-Onco & Vx
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Position Overview Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol. We place high value on efficient, feasibility, most desirable labels, and cost effective, necessitating careful collaboration with operational experts such as colleagues from global clinical trial operation. The clinical monitor will interpret, prepare clinical study reports, regulatory dossier, regulatory responses, and review product label. The clinical research physician will also prepare and review manuscript for publication. The clinical research physician will also function as clinical monitor for study protocol. In this role, this individual will work with study team to ensure safety/efficacy information adequately captured and review serious adverse events. Clinical research physician will review and approve monitoring plan/reports/data listings To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders (KOLs) and internal key stakeholders such as medical affair, and marketing and regulatory affair etc. The clinical physician will be involving in introducing new compounds in development to China KOLs and seek feedback for our clinical development plan as needed. The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities. Clinical research physician in China will report directly to the Head of Clinical Research in China Development Center. Other key points of contact in the organization will include emerging market development colleagues in US, project team in US, regulatory affair colleagues in China, medical affair, project management, and clinical trial operation. Requirements： A MD(or MD/PhD) or Bachelor in medicine (at least 5 year medical school graduates) with postgraduate training in clinical medicine or pharmacology or master degree in clinical medicine. Previous experience of clinical research is highly desirable. The candidate who is ideally suited for this position will be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills. Excellent language skills in both English and Chinese (fluent in verbal and written), previous track record of protocol and study report writing is highly desirable. The position may require the flexibility to work outside of the area of primary medical specialization. |
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