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更新:2024-05-22
血液瘤临床中国区负责人(J10255)
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北京  | 10年  | 硕士  | 社招
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职责描述:
1. Build and manage a high-performance Clinical Science team, enable CARsgen global clinical development program implementation.
2. Generate and develop the overall medical strategy to support clinical development activities.
3. Deliver timely and high-quality implementation of clinical development strategies and lead the IND or NDA submissions of new products in China.
4. Ensure effective design and review of study protocols, study enrollment, data analysis/interpretation, and provide clinical support to regulatory process.
5. Work closely with Regulatory Affairs and Early Discovery to provide scientific input on unmet medical needs assessment and to ensure an optimal local registration strategy for new products.
6. Play a key role in developing, fostering relationships, and conducting medical communications with KOLs, academic institutions and government departments.
7. Constantly track and keep updated on clinical research related laws and regulations to ensure study with no compliance issue.
8. Can act as a Medical Monitor, evaluating and managing safety issues on ongoing studies. Provide medical insight in analyzing and interpreting data, and interact with investigators and key opinion leaders.
9. Work in conjunction with Pharmacovigilance to ensure timely reporting of safety signals to internal and external customers e.g. regulatory authorities.
10. Work with experts in pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics, drug safety, translational and regulatory strategy to generate robust and flowless clinical development plans, target product profiles, protocols and study reports.
11. Assist in the development of case report forms used to capture data from clinical protocols.
12. Responsible for the department budgeting, objective setting, and performance management.
13. Accountable for the expected deliverables and outcomes of the department in accordance with business and projects requirements.
14. Continually and proactively provide recommendations to improve and enhance the work efficiency of Clinical Science team.
任职要求:
1. MD degree with advanced scientific training/experience in Hematology.
2. 10+ years of working experience including 5+ years of people management in pharmaceutical or biotechnology industry.
3. Experience of protocol design and clinical trial implementation in phase I-III in oncology area are preferred.
4. Therapeutic area knowledge in oncology, especially in hematology and cellular immunology, or an oncologist is preferred.
5. First-hand experience in immunotherapy, cell therapy, and/or gene therapy is a plus.
6. International clinical research or medical team experience would be a plus.
7. Knowledge of GCP, NMPA regulations and guidelines.
8. Capability for strategic thinking and planning, and hands-on experiences.
9. Demonstrate the ability to organize, plan and prioritize the multiple projects.
10. Demonstrate the ability to analyze complex situations and proactively identify opportunities/issues, and effectively solve problems that is cross functional.
11. Previous experience of interacting with regional and national health authorities is desirable.
12. Display the highest level of integrity that is aligned with CARsgen value.
13. Proficient in English and Chinese, strong verbal and written skills.

其他信息
语言要求:英语
工作地址
北京E园EPARK(雅宝路社区)
公司介绍
科济药业(股票代码:2171.HK)于2014年在上海开始运营,是一家在中国及美国拥有业务的生物制药公司,主要专注于治疗血液恶性肿瘤和实体瘤的创新CAR-T细胞疗法,截至2022年6月30日,公司已在全球申请专利300余项,其中授权专利70项。
科济药业拥有12个候选产品,均为自主研发且拥有全球权益,已获8个CAR-T产品的临床试验许可(IND),数量在中国所有CAR-T公司中居于前列,也是目前仅有的一家在血液瘤(CT053)和实体瘤(CT041)领域均有产品获得“再生医学先进疗法”(RMAT)和“优先药物”(PRIME)认定的CAR-T公司。
其中,CT053(即“泽沃基奥仑赛注射液”)是升级的全人抗BCMA自体CAR-T细胞候选产品,用于治疗复发/难治多发性骨髓瘤。2022年10月,泽沃基奥仑赛注射液新药上市申请(NDA)获国家药品监督管理局受理,并被纳入优先审评。科济正在北美进行关键性2期试验,并计划于2023年向美国FDA提交生物药物上市许可申请(BLA)。
CT041是全球**获得临床试验许可的靶向CLDN18.2的CAR-T细胞候选产品,也是目前**进入到确证性II期临床试验的用于治疗实体瘤的CAR-T细胞候选产品。CT041在2021年ESMO大会公布的研究者发起试验数据表明,在既往接受至少2线治疗失败的18例胃癌患者中,客观缓解率达61.1%。2022年5月,CT041研究者发起试验的I期期中分析结果在《Nature Medicine》上发表,是**发表于学术期刊的迄今为止**样本量的CAR-T细胞治疗实体瘤临床研究。2022年6月,CT041中美注册临床试验数据于ASCO年会**公布,进一步显示了CT041前景光明的治疗效果及良好的安全性。科济药业计划于2024年上半年向中国国家药监局提交NDA,公司亦计划于2022年下半年在北美启动一项2期临床试验,并于2024年向美国FDA提交BLA。
在由经验丰富的学术专家和行业资深人士组成的管理团队的领导下,科济药业在全国同类公司中率先建立了自主、垂直一体化的生产能力,包括质粒生产、慢病毒载体生产和CAR-T细胞生产。科济药业在上海市金山区建成商业化生产厂房,取得了中国**张CAR-T细胞疗法的药品生产许可证,预计每年可支持多达2000名患者的CAR-T治疗;同时,位于美国北卡罗来纳州总建筑面积3300平方米的CGMP生产工厂已启动运营,其具备每年为700名患者生产产品的能力,将显著提升科济药业的自体CAR-T细胞产品生产能力,并将支持公司在北美和欧洲的临床研究和早期商业化。
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