工作职责:
负责创新小分子和生物技术药的药效研究整体方案制定、评价方法建立、研究质量和进度控制、关键技术难题解决等研发环节的全过程管理;
追踪国际先进药效研究的发展趋势,特别是能反映人体内疾病真实情况的新平台新技术,降低研发风险,提升团队成药性评价水平和研发效率;
与药代、毒理、临床等专业团队一起,分析研究在研品种的临床特点,提炼与临床标准治疗方案之间的优势,进一步提升成药性评价的科学性和系统性,并应用于临床前和临床研究中,提高临床研究的成功率;
负责创新药物药理毒理申报资料的撰写和审核;
负责相应团队的培训和建设、指挥与管理。
任职要求:
学历要求:博士学历。
专业要求:药理学、药学、医学、生物学等相关专业。
工作经验和能力要求:
在国内外大型制药公司6年以上创新药物药效研究经验,并在研发过程中担任项目负责人,成功推动项目进入临床或产品上市;或在CRO、科研院校长期从事药效研究;
具备深厚的创新小分子或生物技术药的体内外药效研究能力,熟悉分子、细胞、尤其是动物模型等不同层次的药效评价技术与方法;
熟悉新药研发流程,把握药效与药代、毒理等研究的相互联系,善于衔接相关研发环节、推动系统的成药性评价工作顺利开展者优先;
熟悉药品研发注册的相关政策和法规,能指导申报资料撰写者优先;
具有良好的组织协调能力和团队管理能力。
职业素养:积极敬业、主动进取、责任感强、正直向上。
语言要求:良好的英文阅读、中文沟通及写作能力。
Job Description:
Responsible for pharmacological research of novel small molecule and biologic drugs, and management of R&D process including plan design, method development, quality and progress control;
Follow trends of drug discovery from a pharmacological perspective, especially in novel platforms and technologies that improve depth and efficiency of project teams, reduce R&D risks, and help translation into the clinic.
Closely work with teams in pharmacokinetics, toxicology, and clinical research, analyze clinical features of drug candidates in the pipeline, identify their potential in standard of care, and improve success rate in the clinic with better scientific and holistic evaluation of drug candidates.
Responsible for writing and reviewing pharmacology and toxicology reports for IND applications;
Responsible for training, managing, and leading project teams.
Job requirements:
PhD in pharmacology, pharmacy, medicine, biology or related disciplines.
6+ years experience in pharmacology or related departments of domestic and international large pharmaceutical companies; a project lead and able to successfully advance projects into the clinic, or an employee in CRO companies or research institutions for extended periods.
Able to carry out in vitro and in vivo pharmacological studies of small molecules or biologics, and evaluate techniques and methods at molecular and cellular levels, and in animal models.
Familiar with R&D processes, understanding relationships among different areas of research especially pharmacology, pharmacokinetics, and toxicology, and able to identify connections for each stages of R&D; ability to approach R&D systematically preferred
Familiar with relevant policies and regulations of new drug registration; ability to guide the preparation of IND applications preferred;
Good organizational, managerial, and team work skills.
Work proactively, with dedication, strong sense of responsibility, and integrity;
Good communication skill, fluent in Chinese, proficient in English reading.
职能类别: 医药技术研发管理人员
联系方式
上班地址:成都市温江区海峡两岸科技园新华大道2段666号
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