上海招聘

(工作地点：北京）

工作职责

To support line manager to prepare medical document package including protocol synopsis, briefing book, investigator’s brochure, protocol, ICF, patient dairy, study report, safety summary, efficacy summary etc; for regulatory submission and ethical committee submission together with internal and external partners

To perform frequent clinical data review activities in clinical trials to ensure compliance of documentation to GCP, SOPs, study protocol, and relevant guidelines in pharmacovigilance as well as to ensure data integrity and patient safety protection

To support or lead data publications with doctors/investigators/internal needs

Proactively monitor the literature for new scientific information; identifies publications that would be of scientific and business interest, analyzes and communicates relevance of information internally in an accurate, balanced and timely manner.

Keeps an eye on developments in given scientific field and provide current awareness to internal stakeholders. Support to maintain and update medical information database of Carsgen’s product and competitor intelligence

Provide medical related training on demand

Work with line manager to ensure communication materials and activities are conducted with due regard to all applicable local, regional, global and national laws, regulation, guidelines, codes of conduct, company policies and accepted standards of best practice.

任职资格

Medical, or pharmacology or biology related master degree, or above.

At least 1 years relevant working experience in clinical/drug safety/ or relevant experience in pharmaceutical company. Oncology disease area and/or relevant experience is preferred.

Fluent English communication.

  

科济生物简介

科济生物医药（上海）有限公司（以下简称“科济生物”）是聚焦于CAR-T细胞、抗体等肿瘤免疫治疗药物的创新型生物医药企业。

科济生物成立于2014年，总部位于上海，在中国和美国设有实体运营中心。目前公司已建立了广泛的CAR-T候选产品研发管线，开发了能够覆盖大部分实体瘤及血液肿瘤的高效特异性CAR-T及抗体药物候选产品，以满足日益增长的医疗需求。公司已率先启动了多项治疗复发/难治性实体瘤的CAR-T临床研究项目，包括针对肝细胞癌（HCC）和肺鳞癌的CAR-GPC3-T项目，CAR-EGFR / EGFRvIII-T试验用于胶质母细胞瘤，CAR-Claudin18.2-T用于胃癌和***癌等的临床研究。目前科济生物已经获得多项国内外的CAR-T细胞新药临床试验许可，其中BCMA CAR T细胞药物还分别获得美国和欧盟药监局的"再生医学先进疗法（RMAT）"和"优先药物（PRIME）"资格。

此外，科济生物还拥有治疗性抗体药物的研发平台，其领先的针对Claudin18.2的人源化单克隆抗体已获得国家药监局（NMPA）的IND批准。

  展望未来，科济生物将秉承“科创济世”的价值观，积极与国内外顶尖研究机构、知名医院合作，推进各种先进治疗手段的研制，从而造福更多肿瘤患者。