職位描述
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Department: Clinical Development
Report to: Medical Director
Work location: Shanghai(Minhang District) or Shijiazhuang(Yuhua District)
Major responsibilities:
1、Assist clinical development head and provide input in asset medical strategy and clinical
development plan
2、Design and develop study protocol
3、Responsible for leading clinical study teams, monitoring overall study integrity, and review,
interpretation, and communication of safety and efficacy data
4、Oversee project-related education of investigators, study site personnel, vender and
internal staff
5、Oversee drug safety and pharmacovigilance compliance
6、Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
7、Contribute to company’s planned regulatory filings including authoring clinical sections for
INDs, NDAs, and other related documents
8、Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing
the literature, attending medical/scientific meetings, and through personal interchanges
with consultants, thought leaders, investigators and internal stakeholders
9、Author manuscripts and collaborate with cross-functional colleagues and thought leaders to
meet publication plan objectives
10、Present at scientific, medical and regulatory meetings
Requirements
1、Clinical Medicine degree and clinical training experience are required 臨床醫學教育和訓練
背景;
2、Advanced degree (Master, Doctoral), and Oncology/Hematology training/practice
experience are preferred 血液學,腫瘤學專業方向,碩士或博士;
3、1 years clinical practice experience 2 年以上臨床實踐經驗, or 2 years of experience in
pharmaceutical or biotech 2 年以上生物制藥領域經驗;
4、Study medical monitoring experience in Phase I, II trials ,Phase I,II 實驗經驗,
5、Proven ability to provide scientific and clinical expertise to a clinical development program
6、Strong strategic thinking, communication and execution skills
7、Able to work effectively in a team/matrix environment 能夠在團隊中或者矩陣環境中有效工作
工作地點
地址:上海虹口區上海-虹口區凱德龍之夢205室


職位發布者
HR
河北森朗生物科技有限公司

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制藥·生物工程
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100-199人
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私營·民營企業
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石家莊高新區黃河大道136號1號樓512、513室