Job Description

Job responsibilities:

1. Deeply understand the development goals and clinical value orientation of the project, as well as competition/clinical research/supervision/intellectual property/transformation and other cross-professional collaborative research needs, and deeply analyze the safety competition and positioning strategy of the project from the target disease field of the project. To comprehensively formulate the overall and current objectives of toxicology research, form the research framework and program points, and coordinate with the organization of resources and strength inside and outside the professional team to achieve the objectives and functions of professional research;

2. Formulate and guide toxicology strategies from project initiation to product launch, supervise and guarantee the reliability, scientificity, rationality, efficiency and cost-benefit ratio of research results through the construction and improvement of internal procedure-standard-technical requirements and the guidance and review of toxicology research of specific projects;

3. Plan and guide the technical capacity building of toxicology research system and train toxicology professionals;

4. Timely analyze and solve cross-team research problems within the scope of the overall goal of the major or related to the major, guide or collaborate with resources to solve difficult problems within the major, conduct comprehensive discussions on stage results and form professional judgments, and put forward discussions and suggestions or reference for decision-making;

5. Have a deep understanding of the technical principles and applications of the major, and creatively apply professional technologies to project-related special matters or cross-professional research support;

6. Deeply understand the guidelines and practices of various European, American and Chinese regulatory agencies for toxicology and safety research requirements of various products throughout the life cycle, formulate research strategies that meet regulatory needs, and coordinate with the drug administration to carry out international and domestic regulatory communication on toxicology; 7. According to the company's project planning and needs, review the evaluation and formulation of toxicology related content in the whole life cycle of external cooperation projects, and provide strategies and schemes for project initiation, introduction and development;

8. Other key work related to toxicology system development and planning and project lifecycle toxicology;

Job Requirements:

1. Doctor, major in pharmacology/pharmacy/Medicine/biology, with more than 15 years of continuous working experience in pharmaceutical companies or drug development biotech.

2. More than 15 years of industry experience in innovative project-based drug toxicology research and 10 years of continuous experience in corresponding team management, technical capacity building and project development;

3. Experienced in the successful implementation of toxicological research strategies, plans and protocols at all stages of the entire life cycle (project initiation, discovery, IND, clinical and post-market) of innovative small molecule and biotechnology drugs;

4. Have a deep understanding of toxicology in all stages of product research and development in various disease fields, and be able to establish and continuously improve the systematic capabilities of various research, including technical capacity building, research norms and templates, processes and systems;

5. Have a deep understanding of drug administration regulations and guidelines related to toxicology and safety research of small molecule and biotechnology drugs in Europe, the United States and China, and the requirements of review practice; be competent in communicating with various planning and regulatory agencies; be able to integrate the requirements of toxicology and related professional drug administration registration into the research practice of toxicology team in a complete and in-depth way;

6. Have the ability to use internal and external resources to lead the team to develop new technologies, new tools and new methods, solve problems that cannot be solved by existing methods, create considerable project value and significantly reduce development risks.

7. Participate in the formulation of industry rules and norms in the technical field, with domestic and international industry influence is preferred;

8. Experience in ADC, nucleic acid drugs and gene therapy is preferred;

9. Experience in FDA review is preferred

10. The specific job rank will be determined according to the comprehensive qualifications of the candidate.

岗位职责：

1. 深刻理解项目的开发目标与临床价值导向、针对竞争/临床研究/监管/知识产权/转化以及其他跨专业协同的研究需求，从项目的目标疾病领域深刻分析项目的安全性竞争以及定位策略，从而综合性的制定毒理学研究的整体和当前阶段目标、形成研究框架和方案要点，并领带与组织协同专业团队内外的资源和力量，达成专业研究的目标和职能；

2. 从立项到产品上市的全程毒理学策略的制定与指导，通过内部流程-规范-技术要求的建设完善以及对具体项目的毒理研究的指导与审核，督促和保障研究结果的可靠性、科学性、合理性、效率和成本效益比；

3. 规划和指导和落地毒理研究体系的技术能力建设，培养毒理学专业人才；

4. 及时分析解决专业总体目标范畴内或和专业有关的跨团队研究问题，指导或协同资源力量解决专业内的困难问题、对阶段性结果进行综合研讨并形成专业判断，向上提出讨论和建议或者决策参考；

5. 深入理解所在专业的技术原理和应用，创造性的将专业技术应用于项目相关的特别事项或跨专业研究的支持中；

6. 深入的理解欧美中国各类监管机构对各类产品全生命周期的毒理学与安全性研究要求的指南和实践，制定符合监管需求的研究策略，并协同药政开展国际国内毒理学相关监管沟通； 7. 根据公司项目规划及需要，审核外部合作项目全生命周期内毒理学相关内容评估与策略制定，为项目的立项、引进、开发提供策略和方案；

8. 其他与毒理学体系发展和规划以及项目全生命周期毒理学有关的关键工作；

任职要求：

1. 博士，药理/药学/医学/生物学专业方向，在制药企业或药物研发biotech有连续15年以上工作经验。

2. 在基于项目的创新药物毒理学研究方面有15年以上的工业界工作经验，并在相应团队管理、技术能力建设和项目开发方面有连续10年或以上的经验；

3. 在创新小分子和生物技术药物的全生命周期（立项、发现、IND、临床以及上市后）各个阶段均具有资深的毒理学研究策略-计划-方案与成功实施的经验；

4. 具备对毒理学在各类疾病领域产品各个阶段研发中的深刻理解，能够建立并持续完善各类研究的系统能力，包括技术能力建设、研究规范与模板、流程和制度等；

5. 对小分子和生物技术药物的欧美和中国的毒理和安全性研究相关药政法规指南以及审评实践要求有深刻的理解，能够胜任各类规划与监管机构沟通，能够将毒理学药政注册要求以及相关专业的药政注册要求完整深入的整合到毒理学团队的研究实践中；

6. 具有利用内外部资源，带领团队开发新技术、新工具、新方法，解决现有方法不能解决的问题，创造可观的项目价值，显著降低开发风险的能力。

7. 参与本技术领域内行业规则、规范的制定，具有国内、国际行业影响力的优先；

8. 在ADC、核酸药物以及基因治疗领域也有相应经验的优先；

9. 具有美国FDA审评工作经验的优先；

10.具体岗位职级将根据候选人综合资质确定。

欢迎海外人员考虑回国发展，工作地点：中国上海浦东新区

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