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DMPK VP
50-99K/月上海市-上海/博士及以上/5-10年
熊女士2天前来过
成都方向标尺人力资源服务有限公司
职位详情
岗位职责
Job responsibilities:
1.According to the company's development strategic planning throughout the DMPK platform development strategy, formulate the department's work objectives, plans and lead the implementation;
2.Responsible for the whole process management of DMPK (ADME and PK) research in the development of new drugs, such as experimental design, program development, evaluation process establishment, research quality and progress control, key technical difficulties, and other research and development links;
3.Coordinate with internal pharmacology, pharmacodynamics and other professional teams to carry out systematic evaluation of drugability and accurate evaluation of pharmacokinetic properties of customer products;
4.Closely establish relationships with domestic and foreign customers, increase customer sources, and help the company's DMPK R&D platform to expand domestic and foreign markets;
5.Responsible for the construction and operation management of the DMPK platform, departmental cost control, budgeting, etc.; set up, train, guide, and manage the work of the platform project personnel, including internal research and development, project management, and project execution;
6.Tracking domestic and international cutting-edge industry dynamics, regulations and technical requirements, and can provide the company with effective information summarization and suggestions/opinions;
7.Responsible for controlling the cross-departmental cooperation of the project, communicating closely with other business teams to ensure better completion of the experimental project, and providing relevant technical support;
8.Other work assigned by the CEO.
Job Requirements:
1. PhD degree in pharmacy and related majors, with at least 10 years of relevant work in new drug R&D companies and CRO companies;
2. proven project management experience in in vitro and in vivo PK studies and extensive team management manager;
3. have a deep understanding of scientific research and regulations on preclinical efficacy, pharmacokinetics, toxicology, and clinical pharmacokinetic pharmacology studies; keep abreast of the domestic and international cutting-edge development trends of related technologies, and have an understanding of the research progress of new molecular entities such as protein degradation-targeted chimeras, antibody-coupled drugs, peptide-coupled drugs, peptide drugs, and nucleic acid drugs, and other drug research progress. Ability to guide others to complete relevant preclinical pharmacokinetic studies, grasp the progress of the research project, and solve the problems in the work;
4. have a complete experience of CFDA/FDA IND filing for new drug projects, and understand the filing process and related matters;
5. be familiar with Winnonlin and other software commonly used in DMPK studies, and be able to review and judge relevant data;
6. understand the process of early drug development and the regulations and guidelines of ICH, FDA, CFDA;
7. excellent listening, reading and writing skills in Chinese and English, and can skillfully communicate with overseas customers;
8. responsible, strong learning and absorption ability, good interpersonal communication skills and team spirit.
1.According to the company's development strategic planning throughout the DMPK platform development strategy, formulate the department's work objectives, plans and lead the implementation;
2.Responsible for the whole process management of DMPK (ADME and PK) research in the development of new drugs, such as experimental design, program development, evaluation process establishment, research quality and progress control, key technical difficulties, and other research and development links;
3.Coordinate with internal pharmacology, pharmacodynamics and other professional teams to carry out systematic evaluation of drugability and accurate evaluation of pharmacokinetic properties of customer products;
4.Closely establish relationships with domestic and foreign customers, increase customer sources, and help the company's DMPK R&D platform to expand domestic and foreign markets;
5.Responsible for the construction and operation management of the DMPK platform, departmental cost control, budgeting, etc.; set up, train, guide, and manage the work of the platform project personnel, including internal research and development, project management, and project execution;
6.Tracking domestic and international cutting-edge industry dynamics, regulations and technical requirements, and can provide the company with effective information summarization and suggestions/opinions;
7.Responsible for controlling the cross-departmental cooperation of the project, communicating closely with other business teams to ensure better completion of the experimental project, and providing relevant technical support;
8.Other work assigned by the CEO.
Job Requirements:
1. PhD degree in pharmacy and related majors, with at least 10 years of relevant work in new drug R&D companies and CRO companies;
2. proven project management experience in in vitro and in vivo PK studies and extensive team management manager;
3. have a deep understanding of scientific research and regulations on preclinical efficacy, pharmacokinetics, toxicology, and clinical pharmacokinetic pharmacology studies; keep abreast of the domestic and international cutting-edge development trends of related technologies, and have an understanding of the research progress of new molecular entities such as protein degradation-targeted chimeras, antibody-coupled drugs, peptide-coupled drugs, peptide drugs, and nucleic acid drugs, and other drug research progress. Ability to guide others to complete relevant preclinical pharmacokinetic studies, grasp the progress of the research project, and solve the problems in the work;
4. have a complete experience of CFDA/FDA IND filing for new drug projects, and understand the filing process and related matters;
5. be familiar with Winnonlin and other software commonly used in DMPK studies, and be able to review and judge relevant data;
6. understand the process of early drug development and the regulations and guidelines of ICH, FDA, CFDA;
7. excellent listening, reading and writing skills in Chinese and English, and can skillfully communicate with overseas customers;
8. responsible, strong learning and absorption ability, good interpersonal communication skills and team spirit.
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公司信息
某医药公司
- 长春
- 1000-9999人
- 生物制药
- 国企
- 已上市
金赛药业是中国基因工程药物质量管理示范中心，国家基因工程新药孵化基地，国家科学技术进步二等奖获得者，拥有亚洲重组人生长激素生产基地。
金赛药业是长春高新（股票代码000661）控股子公司，行政总部和生产总部设于长春。
金赛简介
金赛人的征途，源自一次勇敢的开始。专注与卓越贯穿了金赛药业20年的发展历程。全国有700万矮小儿童憧憬长高梦想，有4300万家庭面临不孕不育困扰。他们与梦想擦身而过，生命本该没有遗憾。
生长激素是控制人体生长的核心蛋白质。我们探寻生长潜能，让梦想不再遥不可及。1998年上市国产生长激素粉剂，2005年上市生长激素水剂，2014年上市聚乙二醇长效生长激素，2015年上市国产重组人促卵泡激素，2016年上市生长激素隐针电子注射笔。今天，金赛拥有亚洲重组人生长激素生产线，是长效、水剂、粉剂三大系列重组人生长激素生产基地。我们已经帮助全球20万矮小儿童实现了长高梦想。
专注卓越，追求理想的工匠精神就是我们20年来不断前进的动力和灵魂。金赛药业的产品质量内控标准全面优于国家标准，多个产品被中检院优选为国家标准品的提供单位。金赛药业是国家基因工程药物质量管理示范中心，国家级基因工程新药孵化基地。2015年，金赛药业荣获国家科学技术进步二等奖。
我们持续关注领域内学术学科的发展，为儿科中青年医生提供学术及教育支持。我们还肩负着提升国民身高体质的社会责任，不断贡献温暖力量。
我们每年投入巨额资金用于未来产品线的研发和搭建。目前，我们的在研产品涵盖了生殖、肿瘤、自身免疫、眼科、神经系统以及代谢疾病等领域。为了人类健康和生命质量的改善，我们砥砺进取，义无反顾。
未来，我们将持续关注儿童长高领域，让中国人多长高10公分。我们也将致力于不孕不育领域产品线的研发，在未来5年成为该领域的领导品牌，解决大龄女性不孕不育难题。我们还将专注于抗衰老领域，让即将迈入老龄社会的中国老年人健康幸福。这就是我们的伟大梦想。我们将用专注和智慧，向世界展示令人震撼的民族力量。
主要产品
金赛药业是“十二五”期间，我国坚持创新驱动发展战略所涌现出现来的典型企业。1998年，金赛药业发明了基因重组分泌型表达技术，上市国产重组人生长激素粉针，成功填补国内空白。2005年，金赛药业开发了重组人生长激素非晶态蛋白稳定技术，解决了生长激素在水溶液中不稳定的问题，推出亚洲重组人生长激素水针剂，不仅高质量天然结构，且诱导抗体检出率为零。2008年，公司上市具有国家发明专利的新药、全球唯一的rhGM-CSF的凝胶剂。2014年，金赛药业创建了聚乙二醇生长激素偶联技术，率先推出全球长效型重组人生长激素，获得3项国家发明专利，结束了全球近60年来矮小儿童长高需要每天注射一次生长激素的治疗历史，具有划时代意义。2015年，在国内上市了促排卵重组人促卵泡激素金赛恒，解决了促卵泡素长期依赖进口的局面。2016年金赛药业上市生长激素隐针电子注射笔，消除儿童注射恐惧，提高患儿依从性，保证更好的治疗效果。从“全国”到“亚洲”再到“全球”，是金赛人秉持创新突破的精神，一步一个脚印炼成的。
