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(yī)學(xué)教育和訓(xùn)練
背景;
2、Advanced degree (Master, Doctoral), and Oncology/Hematology training/practice
experience are preferred 血液學(xué),腫瘤學(xué)專業(yè)方向,碩士或博士;
3、1 years clinical practice experience 2 年以上臨床實踐經(jīng)驗, or 2 years of experience in
pharmaceutical or biotech 2 年以上生物制藥領(lǐng)域經(jīng)驗;
4、Study medical monitoring experience in Phase I, II trials ,Phase I,II 實驗經(jīng)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(tuán)隊中或者矩陣環(huán)境中有效工作
工作地點
地址:上海虹口區(qū)上海-虹口區(qū)凱德龍之夢205室
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求職提示:用人單位發(fā)布虛假招聘信息,或以任何名義向求職者收取財物(如體檢費、置裝費、押金、服裝費、培訓(xùn)費、身份證、畢業(yè)證等),均涉嫌違法,請求職者務(wù)必提高警惕。
職位發(fā)布者
HR
河北森朗生物科技有限公司
-
制藥·生物工程
-
100-199人
-
私營·民營企業(yè)
-
石家莊高新區(qū)黃河大道136號1號樓512、513室
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注:聯(lián)系我時,請說是在河北人才網(wǎng)上看到的。
