职位详情
年终奖金
股票期权
绩效奖金
五险一金
领导好
发展空间大
扁平管理
管理规范
技能培训
岗位晋升
We are seeking a Medical Director to lead clinical trials for gene-editing based therapeutics. The role requires a resourceful, well-organized, strategic focused individual to drive multiple operational tasks. The candidate will work closely with clinical operations, researchers, and external CROs to bring early projects into clinical development.
Responsibilities:
1. Design robust clinical studies
2. Develop clinical study protocols and associated clinical study documents
3. Identify and establish relationships with KOLs and principal investigators
4. Select clinical investigators; providing guidance to investigators on a study.
5. Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs.
6. Provide medical supervision for contract research organizations and protocol procedures.
7. Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory data.
8. Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE) reporting, and follow-ups.
9. Author, review written materials and provide editorial comments for clinical study reports and manuscripts.
10. Develop budgets and timelines for the clinical development team.
Minimum Qualifications:
1. M.D. is required.
2. Formal training in the areas of Internal Medicine /Pediatrics / Endocrinology /Neurology or related fields.
3. A minimum of 2+ years of clinical trials and managerial experience in drug development
4. Excellent interpersonal and public speaking skills are required for this high visibility position.
5. Demonstrated ability to work in a matrix environment with cross-functional teams.
Preferred Qualifications:
1. Experience in rare disease would be a plus.
2. NDA / BLA experience is strongly preferred.
3. Global clinical development experience is required, and global filing experience is strongly preferred.
4. Background in gene therapy is preferred.
5. Experience in pre-clinical development is preferred.
6. Portfolio management experience would be a plus.
其他信息
行业要求：全部行业
公司介绍
锐正基因成立于2021年7月，主要聚焦于细胞内包括细胞核内靶点，基于新一代安全、高效、靶向性优异的基因编辑、RNA编辑和递送技术，行业先进的算法的脱靶效应分析手段，以及经过行业验证的CMC工艺开发、GMP生产和商业化经验和能力，致力于为全球患者提供能够治疗严重甚至危及生命的先天性遗传疾病和后天获得性疾病的创新药物和治疗方案。
体内基因编辑技术是当下全球最 前 沿的生物技术之一，可以从根源的基因层面出发解决患者的问题，甚至达到一次性治愈的效果，拥有无可比拟的潜力和优势。我们采用以分子为基础的工艺，不涉及昂贵而复杂的细胞和病毒，我们的基因编辑技术平台和递送系统的递送效率和靶向特异性都处于行业先进的水平，我们的团队在项目和企业运营都有经过验证的全周期经验，这些特点使得公司在产品研发，产业化和商业化方面均拥有行业优势。
公司成立两个月后就完成了数千万美元种子轮融资。该轮融资由知名医疗投资机构君联资本领投、Cormorant跟投，融资额居近年来中国生物药行业初创团队融资规模前列。
目前公司拥有超1500平方米实验室，购置近5000万元的高端设备。锐正基因实验室被评为苏州市市级重点实验室。
公司已有数个项目正在按照计划快速推进。
锐正基因具有独特的竞争优势：
先进的新一代基因编辑技术：低脱靶率/无脱靶的DNA 编辑技术、新载体的应用、高效编辑与RNA编辑技术、新靶点发现能力。
公司创始人王永忠博士、共同创始人陶佳林博士、研究负责人Fuxin Shi博士均来自国内外知名医药企业和世界著 名大学，在全球生物创新药物研发、生产和商业化，以及企业运营等多方面均有丰富的成功经验。核心技术团队成员均有生物医药行业背景近10年经验，具备经过验证的创新生物药项目管理与CMC快速转化能力。公司员工博士学历占28.3%，硕士学历占35%，均毕业于国内外著 名大学。公司荣获苏州市东吴领 军人才团队，也是2022年苏州市吴中区唯 一 一个人才团队。
经过验证的成功开发、产业化与商业化创新生物药全周期和全价值链的能力，而不仅仅是大部分创业团队所拥有的局限于某一个阶段的能力。
雄厚且专注医疗健康行业的国内外头部资本支持；行业资源广泛。
