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更新:2024-04-30
医学科学总监(J12824)
4.5-6.5万
上海闵行区  | 5-10年  | 硕士  | 社招
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职位详情
职责描述:
1.Maintain scientific and clinical knowledge in the specific therapeutic and disease areas
2.Contribute to the clinical development strategy for the relevant therapeutic/disease areas
3.Conduct literature searches and analyze the data and information necessary to create the clinical development plan
4.Take medical responsibilities for clinical trials:
 Develop clinical study design for internal reviews
 Provide support to clinical operation and other groups to develop Informed Consent Form (ICF), Case Report Form (CRF), CRF instructions, etc
 Review and/or write additional clinical science documentation and/or provide clinical science input into other documentation managed by other groups
 Collaborate with data management and other groups to conduct medical review of study data, identify and evaluate the data outliers and query the sites
 Collaborate clinical operation and other groups to identify and evaluate the protocol deviations
 Review the study report and respond to authority’s inquiries
 Prepare or review abstracts, posters, and content for scientific events etc.
5.Collaborate with regulatory and other team to complete and submit regulatory filings and other regulatory documentation.
6.Collaborate with PV to review safety data and provide medical support and judgement to ensure the high standards of clinical safety
任职要求:
1.Master’s Degree at least in life sciences required. The experience in oncology, hematology or with a broad medical background is preferred
2.Minimal 5 years in clinical practice, pharmaceutical medical affairs or clinical development
3.Able to work within matrix organization and provide leadership
4.Design and implement clinical trials
5.Disease area knowledge, including key scientific publications
6.Well-versed in medical aspects of GCP, ICH, CFDA
7.Good scientific thinking, agility in learning and good communication skills

工作地址
上海-闵行区复星凯特商务运营管理中心
公司介绍
关于复星凯特
复星凯特生物科技有限公司为复星医药与美国Kite Pharma(吉利德科学旗下公司)的合营企业,自2017年创立以来,长期致力于肿瘤免疫细胞治疗的研发,率先于2021年6月获批上市中国第一个CAR-T细胞治疗产品--奕凯达®,成功治疗超500位复发/难治性大B细胞淋巴瘤患者。
2019年12月,公司正式启用位于上海张江的近10000㎡的CAR-T产业化生产基地,并建设超2000㎡的细胞治疗研发中心,成功汇聚并培养了涵盖海内外高学历、高素质研发科学家的创新人才团队。
2023年6月21日,复星凯特提交的奕凯达®新适应症上市申请获得国家药监局正式批准。这也标志着,一线免疫化疗无效或在一线免疫化疗后12个月内复发的成人大B细胞淋巴瘤患者将加快获益,迎来治愈希望。
若用人单位提供虚假招聘信息,以担保或其他任何名义收取财物,扣押或以保管为名索要证件,都属于违法行为,应当提高警惕。
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