Non-clinical Head

面议

上海市

刷新时间：2022-08-01

职位描述

Primary Function 主要职能：

Responsible for strategic planning, execution and reporting of non-clinical pharmacology and toxicology studies and overseeing the strategic planning in allied disciplines. Partner closely with other functions to enable seamless transition of product candidates from discovery research to clinical development, and continuous development along with clinical trials, an environment characterized by rapid, integrated decision making.

负责临床前药理和毒理研究的战略制定、执行和报告，监管相关学科的战略规划。与其他部门密切合作，快速整合各部门结果做出决策，以确保候选药物从研发阶段到临床前研究的顺利衔接以及伴随临床开发的后续研究。

Major Responsibilities and Duties 主要职责和任务 :

1. Accountable for the overarching strategy, execution and reporting of non-clinical development programs for product candidates from discovery through regulatory submission and approval.

负责对生物药品研发非临床研究项目发展战略的制定、执行和报告，包括候选药物的发现到提交给法规部门并通过审核。

2. Lead the strategic design and execution of non-clinical pharmacology and toxicology programs in collaboration with a range of internal and external partners including: multiple discipline functions, scientific and academic experts, research laboratories, consultants, co-development partners, and CROs.

通过与内部和外部的合作交流领导生物非临床研究药理学和毒理学项目的战略设计和实施，合作交流对象包括：各职能部门、学术专家、研究所、顾问、合作开发伙伴和CRO。

3. Develop and review study designs. Ensure reagent generation, method development and sample analysis timelines are met. Oversees CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies and ensure that studies are delivered within agreed quality, cost and timeline parameters.

设计和审核研究方案。确保试剂生成、方法开发和样品分析满足时间要求。监管CRO在药理学和毒理学中的研究，包括方案设计和实施、数据分析和阐释，确保CRO的研究在规定时间和预算内达到预期的质量要求。

4. Collaborate with CMC team to ensure coordination of manufacturing activities and support for toxicology and pharmacology studies.

与CMC团队合作确保生产制造活动的合规，支持毒理学和药理学研究。

5. Develop long term bioanalytics strategy in collaboration with bioanalytics team members and external experts.

与生物分析部门包括外部专家密切合作，制定长期生物分析策略。

6. Oversee assay development, validation and sample analyses.

监管检测的开发，验证和样品分析。

7. Partner with clinical pharmacology, pharmacometrics, bioanalytics and safety groups to conduct safety pharmacology and pharmacodynamics and lead toxicity/safety assessment (e.g. for IND submissions).

与临床药理学、定量药理学、生物分析部门和药物安全部门密切合作，牵头毒理学和安全性评估以确保实验的实施符合安全性。

8. Work closely with clinical pharmacology, pharmacometrics and bioanalytics groups to ensure robust PK/PD data is generated to support dose selection for clinical programs, and ultimately NDA applications.

与临床药理学、定量药理学和生物分析部门密切合作，确保得到稳健的PK/PD数据，支持临床研究并最终用于NDA审批。

9. Serve as Non-Clinical Development subject matter expert on project teams supporting the discovery and development. Provide clear updates of non-clinial study design, execution and results relevant to project team programs.

作为非临床研究专家为项目的开发提供专业支持。为项目管理团队提供清晰和最新的非临床研究设计，实施方案和结果。

10. Lead interactions with regulators regarding Non-Clinical Development and author relevant sections of regulatory submission documents (e.g. INDs, NDA/BLA, MAAs) as well as non-clinical sections of Investigators Brochures, CTA applications, IMPDs, etc.).

领导与法规机构在非临床开发方面的互动，撰写需提交文件的相关章节(IND.NDA/BLA.MAA等)包括研究者手册，CTA 申请和IMPD等文件中的临床前研究章节。

11. Work with Quality to ensure non-clinical quality and compliance and development of SOPs to ensure compliance with all applicable regulations, SOPs, policies and guidelines, as needed.

与质量部门合作保证临床前研究符合内部管理规定，遵循相关法律法规和政策。

12. Work closely with contracting team to ensure timely preparation of MSAs, SOWs, work orders, etc. Review and process invoices for approval.

与供应商密切合作，确保MSAs, SOWs和工作订单资料的及时准备。并审核产生的发票。

13. Coordinate CRO selection and vendor qualification (e.g. draft RFPs, conduct capability assessments).

负责协调CRO的筛选和供应商资格认证（如撰写RFP,实施能力评估）。

14. Oversee non-clinical team shape-up and individual career development plan. Provide mentorship through daily work and set up key performance criteria to ensure smooth workflow and working quality.

监督临床前部门建设及个人职业发展计划。通过在日常工作提供指导和设立关键绩效考核指标，确保工作保质保量顺利运行。

Qualifications 资格要求:

1. A PhD in Pharmacology, Toxicology or a related Life Sciences field and at least 10 years of relevant experience in the pharmaceutical drug development (e.g. at a pharmaceutical company, biotechnology company or CRO). Certified personal in this area is preferred.

药理学，毒理学或生命科学领域博士，有至少10年药物开发相关工作经验（制药公司，生物技术公司或CRO）。优先考虑在该领域获得认证的人员。

2. Extensive experience and expertise in animal models for drug development, including PK/PD, and demonstrated track record of successful delivery of completed non-clinical programs.

在药物开发的动物模型有丰富的经验，包括PK/PD, 有成功完成非临床项目的经验。

3. In depth understanding and experience in the design, development and conduct and interpretation of non-clinical toxicology and safety pharmacology studies. Experience with toxicological assessment of biologics(protein-based therapies) strongly preferred.

对设计、执行非临床的毒理学研究和安全药理学研究有深刻的理解和丰富的经验。对生物制剂的毒理研究有经验的优先。

4. Broad experience in the development and validation of relevant assays on multiple technology platforms.

具有在多技术平台上开发和验证相关实验的经验。

5. Thorough knowledge of GLP standards, and solid working understanding of regulatory requirements for preclinical development of biologics products.

对GLP的标准有透彻的了解，对临床前研究的法规及生物制品有深入的认识。

6. Experience in the non-clinical development of biological compounds strongly preferred.

对临床前化合物的筛选有丰富的经验。

7. Must have experience in the conduct of screening toxicity studies, as well IND-enabling toxicity/toxicokinetics and safety pharmacology program.

必须具有毒性筛选的研究经验，包括IND要求的毒性/毒代学实验，及药理学评估。

8. Demonstrated leadership and management skills(including both direct and dotted line reporting relationships).

具有管理和领导能力。

9. Must be able to see the big picture, and connect the dots, while maintaining sufficient focus on details.

具有大局观，既能关注细节又能整合细节。

10. Ability to successfully work with a collaborative, fast-paced project team in an entrepreneurial work environment.

适应团队协作和快节奏的工作环境。

11. Ability to influence, negotiate and successfully communicate with both internal and external stakeholders.

能与内外部利益相关者有效沟通。

12. Excellent organizational, planning, and project management.

优秀的组织能力，规划能力和项目管理能力。

13. Strong communication (oral and written) and interpersonal skills.

优秀的沟通能力和人际交往能力。

14. Ability to present complex pharmacology and toxicology data to a wide range of audiences including: internal project teams, senior management, academic expertise/leaders in the field, regulators and other key external decision makers (e.g. grant reviewers, etc).

具有向不同对象展示复杂药理学和毒理学数据的能力，包括内部项目团队，高级管理人员，学术专家，领域内专家，法规人员和其他外部决策人员。

15. Have experience and proven success in regulatory submissions and defense (e.g. IND and NDA/BLA, and/or MAA submissions) and be able to represent the company to a broad range of external stakeholders including regulators, funding agencies, scientific experts, development partners and experts in the field.

优秀的表达能力，能否向监管部门，投资机构，科学专家，领域内的合作伙伴和专家展示公司，在提交注册并答复过程中有成功经验。

其他要求

招聘人数：10人
职能类别：药理/毒理/药效

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。