Clinical Research Physician上市前医学总监-VP-北京

公司部门: Clinical Development

工作地点:上海

发布日期:2022-03-09

招聘人数:1人

职位类型:生物制药/医疗器械

职位描述:

主要职能:

Key Objectives/Deliverables:

1. 基于cGCP, ICH-GCP和其他相关临床研究指导原则,负责公司在国内外肿瘤及自身免疫疾病方向创新药物的1-3期临床实验的设计与实施;

2. 负责在临床试验过程中提供医学监控与指导,包括数据安全审核、参与安全委员会;负责就医学研究事项与CFDA等监管部门沟通,撰写用于注册申报的医学研究资料;

3. 负责产品研发阶段的医学支持,包括:产品设计的医学知识、同类竞品的医学分析、文献发表医学数据的转化结合、为研发人员提供医学原理解释和医学信息支持等;

4. 为公司的产品组合、项目开发、在研产品(权益)的引进或出让提供医学方面的策略性建议;

5. 根据相关政策与法规,与研究者、伦理委员会、临床研究机构、患者团体和各级监管部门保持有效沟通与合作。

1. Designing and implementing Innocare phase I-II-III clinical trials of innovative drugs in the field of tumors and autoimmune diseases in China and abroad, based on cGCP, ICH-GCP and other relevant clinical research guidelines;

2. Providing medical monitoring and guidance during clinical trials, including data security audits, participation in safety committees; communicating with regulatory authorities such as CFDA on medical research matters, and writing medical research documents for registration;

3. Medical support during the product development phase, including: medical knowledge of product design, medical analysis of competing products, translation and incorporation of medical data published in the scientific literature, providing medical rationale interpretation for Research and Development (R&D), and medical information support;

4. Providing medical strategic advice for Innocare product portfolio, project development, and introduction or transfer of researching products (rights and interests);

5. Maintaining effective communication and cooperation with investigators, ethics committees, clinical research institutions, patient groups, and regulatory authorities at all levels in accordance with relevant policies and regulations.

任职条件:

岗位要求:

Basic Requirements:

1. 至少医学硕士,或生命科学相关专业硕士及以上学位,博士优先考虑;

2. 至少3年在肿瘤或自身免疫疾病治疗领域进行临床试验的经验,有成功地执行从方案设计到全面完成I-III期临床试验的记录;

3. 全面、深入了解新药临床试验的全过程,包括:临床试验的设计、执行、统计/数据管理、中国和国际规范和质量标准、药物警戒的要求等;

4. 了解和掌握GCP 和ICH指导原则,熟悉FDA和NMPA法规。

1. Master or above in Medicine or in Life Sciences-related majors;

2. At least 3 years of experience in clinical trials in the field of oncology or autoimmune disease treatment, with successful implementation records from protocol design to full completion of Phase I-II-III clinical trials;

3. Comprehensive and in-depth understanding of the whole process of clinical trials of new drugs, including: design, implementation, and statistical/data management of clinical trials; Chinese and international norms and quality criteria; and requirements for pharmacovigilance;

4. Understanding and mastering GCP and ICH guidelines, and being familiar with FDA and NMPA regulations.

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