岗位职责：

1. 负责公司创新药临床前药理、药效、药代、安全性评价等相关研究的试验设计，并根据项目特点，考察CRO公司的相关业务水平，为选定CRO公司提供支持；

2. 负责新药研发项目和体内药物筛选试验的选择和评价，临床前药物的药理学评定以及新药临床批件的申报的药理学报告；

3. 负责管理项目药理、毒理试验的进度，制定各时间节点，与CRO公司及时沟通协调，并协助CRO公司解决试验中出现的各种问题，有效推进项目，负责对项目的承担单位稽查，确保项目如期保质完成；

4. 负责药理毒理试验结果的评估，审核CRO递交的试验报告，负责IND资料中药理毒理部分的撰写、整理工作，配合注册人员完成新药申报工作，协助制定临床试验方案，协助CRO公司完成药监局的现场核查；

5. 为现有临床开发项目和已经上市的产品生命周期管理项目提供药理学支持，参与公司新产品的调研、立项及具体实施工作，提交可行性报告；

6. 负责跟踪国外注册申报相关法规和技术，协助新项目研发或引进，评估药理毒理研究方案及成果，参与公司新药研发中医学相关重大技术方案的决策；

7. 根据法律法规要求，协助整理新产品研发注册毒理药理相关材料，及时归档项目注册材料及相关技术研究原始材料；

8. 负责相关SOP的编制、完善和升级，并上报审核；

9. 领导交办的其他事项。

资格要求：

1. 药理学、生物学、医学等相关专业硕士及以上学历，5年及以上小分子药研发及药理、毒理评价相关工作经验；

2. 熟悉相关药物安全性监管要求，包括药物临床试验质量管理规范、ICH相关指南、SOP等；

3. 能够独立完成药理毒理方案制定、数据分析和药物申报工作，从事过小分子化学药物的研发和申报工作且有成熟案例者优先考虑；

4. 了解相关法规和指南，对研发临床过程和决策点有较好认识和理解；

5. 具备较好的英文基础，良好的文献检索能力，熟悉国内外药典等资料的查询；

6. 熟练掌握flowjo、WinNonlin、SPSS、Graphpad等实验数据分析、作图软件；

7. 良好的敬业精神和职业道德操守，保密意识强，具备良好的专业知识和能力，良好的沟通和表达能力、团队合作精神，能接受一定的工作压力。

Job Responsibilities:

1. Responsible for the test design of preclinical pharmacological, efficacy, pharmacogenetic, safety evaluation and other related studies of innovative drugs, and according to the features of the projects, explore the relevant levels of CRO companies and provide support for the CRO companies selection;

2.Responsible for the selection and evaluation of tests for new drug development projects and in vivo drug screening, pharmacological evaluation of preclinical drugs and pharmacological reports for the declaration of new drug clinical approvals;

3.Responsible for managing the progress of pharmacology and toxicology tests, setting up various timelines, communicating and coordinating with CRO companies in a timely manner, and assisting CRO companies in solving various problems that arise during the tests to effectively promote the project, and responsible for auditing institutions undertaking the project to ensure that the project is completed on time and with quality;

4.Responsible for the evaluation of pharmacological and toxicological test results, review the test reports submitted by CROs, write and organize the pharmacological and toxicological sections of IND files, cooperate with registrants to complete the new drug declaration, assist in the development of clinical trial protocols, and assist CROs to complete on-site verification by NMPA;

5.Provide pharmacological support for existing clinical development projects and life-cycle management projects of marketed products, participate in the investigation, establishment and concrete implementation of new products of the company, and submit feasibility reports;

6.Responsible for tracking technology and registration filing related regulations in major countries and regions around the world, assisting in new project development or licensing in, evaluating pharmacological and toxicological research protocols and results, and participating in decision-making on medically relevant major technical solutions in new drug development;

7.Assist in organizing toxicology-pharmacology related materials for new drug R&D registration according to legal and regulatory requirements, and timely archiving of project registration materials and related technical research original materials;

8. Responsible for the preparation, improvement and upgrading of relevant SOPs and reporting to superiors for review;

9. Other tasks assigned by the supervisor.

Qualification Requirements:

1.Master's degree or above in pharmacology, biology, medicine or other related majors, more than 5 years of work experience in R&D and pharmacological and toxicological evaluation of small molecule drugs;

2.Familiar with the relevant drug safety regulatory requirements, including drug clinical trial quality management standards, ICH related guidelines, SOPs, etc;

3. Able to independently complete pharmacological and toxicological protocol development, data analysis and drug declaration work, and those who have engaged in the development and declaration of small molecule chemical drugs and have mature experience are preferred;

4. Have a good understanding of relevant regulations and guidelines, and a strong knowledge and understanding of the R&D clinical process and decision points;

5. Good English basis, good literature search ability, familiar with domestic and international pharmacopoeias and other information search;

6. Proficiency in flowjo, WinNonlin, SPSS, Graphpad and other experimental data analysis and graphing software;

7. Excellent professionalism and ethics, strong sense of confidentiality, good professional knowledge and ability, good communication and presentation skills, teamwork spirit, and ability to accept certain work pressure.