职位描述
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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 临床医学教育和训练
背景;
2、Advanced degree (Master, Doctoral), and Oncology/Hematology training/practice
experience are preferred 血液学,肿瘤学专业方向,硕士或博士;
3、1 years clinical practice experience 2 年以上临床实践经验, or 2 years of experience in
pharmaceutical or biotech 2 年以上生物制药领域经验;
4、Study medical monitoring experience in Phase I, II trials ,Phase I,II 实验经验,
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 能够在团队中或者矩阵环境中有效工作
工作地点
地址:上海虹口区上海-虹口区凯德龙之梦205室
求职提示:用人单位发布虚假招聘信息,或以任何名义向求职者收取财物(如体检费、置装费、押金、服装费、培训费、身份证、毕业证等),均涉嫌违法,请求职者务必提高警惕。
职位发布者
王女士HR
河北森朗生物科技有限公司
- 制药·生物工程
- 100-199人
- 私营·民营企业
- 石家庄高新区黄河大道136号1号楼512、513室
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