毒理是新搭建团队，招3个人，组一个团队；  

一个是SD–ED，作为整个中国区临床前的HEAD

下面配一个AD–D、一个高级科学家；  

SD-ED岗位JD

Key Responsibilities:
·Provide leadership to the preclinical function at Legend Nanjing; Lead a group of scientists to serve as toxicology lead in cross functional development team. Accountable for discovery tox and safety assessment in drug candidate optimization, evaluation and selection. Accountable for safety and toxicology evaluation in IND
·Design and oversee the preclinical toxicology and safety studies (non-GLP and GLP), ensure all conductions in accordance with project needs and in compliance with appropriate standards and/or regulatory guidelines;
·Drive comprehensive safety assessment of drug candidates, develop critical insights from data, provide strategic advice to project teams on candidate selection and go-no-go decisions;
·Author toxicology reports and related sections of regulatory documents (e.g., IB, IND, NDA etc.);
·Effectively communicate strategies, progresses and results with internal teams and external partners (e.g. CROs, ethic committees in healthcare institutions, etc.);
·Evaluate and employ new scientific methodologies to enhance scientific excellence and/or productivity in preclinical safety, proactively research and stay current on all applicable regulatory guidance;
·Identify and manage CROs to support toxicology and safety studies;
·Responsible for budget planning and resource management for the preclinical function.

Qualifications:
·An advanced degree (PhD, DVM, or equivalent) in toxicology, safety pharmacology or related disciplines with 10+ years of relevant experience post graduate and 6+ years in a pharmaceutical or biotech environment;
·Regulatory toxicology and development experience supporting IND and NDA submissions is preferred;
·Board certification is desired but not required;
·Experienced in designing and interpreting in vivo and in vitro studies exploring mechanisms of toxicology and pharmacology in cell and gene therapies;
·Skills and understanding of immunology and immunotoxicology;
·Demonstrated strong decision-making and problem-solving skills;
·Team player with interpersonal and communication skills;
·Excellent analytical and organizational skills, line management experience.
·

职位：Director/Senior Director - Preclinical
招聘在细胞基因治疗领域的资深毒理专家，领导药物临床前安全性研究工作，支持研发管线项目推进至临床阶段。您将与多学科研发团队合作，将创新且有影响力的药物带给全球患者。

主要职责：
·领导临床前安全团队，作为跨职能项目团队中的临床前毒理学代表；
·设计并监督临床前毒理学和安全性研究（非GLP和GLP），确保所有研究按照项目需求并符合相关标准和/或法规指南进行；
·推动药物候选分子的全面安全性评估，以数据为依据生成关键见解，并为项目团队提供战略建议，参与候选分子选择及开发的决策；
·撰写毒理学报告和相关的法规文件部分（如IB、IND、NDA等）；
·与内部团队和外部合作伙伴（如CRO、医疗机构伦理委员会等）有效沟通战略、进展和结果；
·关注、评估并采用新的科学方法，提升临床前安全性研究的科学水平和/或效率，保持对所有适用法规指导的最新了解；
·主导CRO筛选评估和管理，确保外部的毒理学和安全性研究；
·负责临床前安全性研究的预算规划和资源管理。

资格要求：
·在毒理学、安全药理学或相关学科领域获得高级学位（如PhD、DVM或同等学位），并具有10年以上学位获得后的相关经验和6年以上制药或生物技术公司工作经验；
·具有支持IND和/或NDA提交的经验；
·具备设计体内和体外研究以探索细胞/基因疗法毒理机制的丰富经验；
·理解并具备免疫学和免疫毒理学方面的知识和技能；
·具备优秀的分析、决策和问题解决能力；
·具有团队合作精神以及良好的人际交往和沟通能力，具有优秀的组织能力及丰富的管理经验；
·拥有毒理学资格认证者优先，但不是必须。

 毒理高级科学家 岗位JD

Key Responsibilities:
- Lead the innovative gene delivery strategy & technology discovery and development, mainly focusing on next-generation technologies
- Stay ahead with the latest scientific advancements and technological trends in gene delivery fields to ensure Legend Biotech remains at the forefront of the industry
- Design, execute, and interpret research study data to understand the mechanism of action and play an active role in subsequent scientific discussions to drive decisions
- Lead, cultivate, and develop a team of researchers and foster an innovative and collaborative work environment
- Closely collaborate with cross-functional teams, including research, early drug development, CMC, regulatory and clinical development colleagues to ensure the seamless transition of gene delivery technologies from discovery to clinical translation
- Manage timelines and budgets for multiple development projects, ensuring the efficient allocation of resources and adherence to deadlines
- Work with BD team to identify, develop and maintain strategic external partners to enhance research capabilities and innovation
- Other duties will be assigned, as necessary

Minimum Requirements/Qualifications:
- PhD in Viral Biology, Molecular Biology, Genetics, Biochemistry, or related discipline
- Minimum of 10 years of experience in gene delivery research, with at least 5 years focused specifically on viral delivery system
- Demonstrated expertise in the research and development of gene delivery, including Virus like particle (VLP), lentiviral vector, retroviral vector, adeno-associated virus (AAV), and/or next-generation gene delivery technologies
- Proven leadership experience with a strong track record of mentoring and developing direct reports and driving innovative R&D projects
- Excellent communication skills both in English and Chinese, excellent interpersonal relationship, capable of fostering collaboration both within and outside the team
- Strong strategic thinking and problem-solving abilities, with a proven ability to drive robust R&D strategies

主要职责:
-领导创新基因传递策略和技术的发现和开发，主要关注下一代技术
-紧跟基因传递领域的最新科学进展和技术趋势，确保联想生物技术始终走在行业的前列
设计，执行和解释研究数据，以了解作用机制，并在随后的科学讨论中发挥积极作用，以推动决策
领导、培养和发展研究团队，营造创新和协作的工作环境
-与跨职能团队紧密合作，包括研究、早期药物开发、CMC、监管和临床开发同事，确保基因传递技术从发现到临床转化的无缝过渡
管理多个开发项目的时间表和预算，确保有效分配资源并遵守最后期限
-与研发团队一起寻找、开发和维护外部战略合作伙伴，以提高研发能力和创新能力
-必要时分配其他工作

最低要求/资格:
**生物学，分子生物学，遗传学，生物化学或相关学科博士学位
至少10年基因传递研究经验，其中至少5年专注于**传递系统
-具有基因传递技术的研究和开发经验，包括类**颗粒(VLP)、慢**载体、逆转录**载体、腺相关**(AAV)和/或下一代基因传递技术
-具有领导经验，具有指导和发展直接下属和推动创新研发项目的良好记录
优秀的中英文沟通能力，良好的人际关系，能够促进团队内外的合作
-具有较强的战略思维和解决问题的能力，有能力推动稳健的研发战略