广州招聘

Job description:

    

• As study director, perform all kinds of ADME studies to support drug discovery and development in pre-clinical phase
• As DMPK representative, involve into drug discovery projects to provide DMPK support from early drug discovery to IND filling;
• Interpret and present DMPK data in cross functional project teams and provide suggestions on DMPK properties optimization of drug candidates;
• Perform PK data analysis, human PK and efficacious dose predictions;
• Design and perform common ADME assays in vivo and in vitro;
• Identify DMPK issues and communicate effectively to the project teams;
• Responsible for protocol/report writing of DMPK studies, IND filling documents preparation on DMPK aspects;
• Provide support and communicate well with external collaborators on all kinds of outsourced studies;

    

    

Minimum requirements

    

• Ph.D. or equivalent degree in pharmacology, pharmacokinetics, biological or analytical science with 0~3 year’s industry experiences
• Solid knowledge on DMPK with abundant experiences in all kinds of in vivo and in vitro ADME studies;
• Familiar with common DMPK assays and early DMPK compound screening platforms in drug discovery process;
• Familiar with CFDA and FDA guidelines on DMPK aspects as well as IND filling documents preparation;
• Familiar with bioanalytical method development and validation;
• Capable to identify DMPK issues and proactively solve the issues with minimum guidance and help;
• Familiar with DMPK softwares including Kinetica, WinNonlin, etc.
• Familiar with human PK projection using different approaches;
• Ability to work with and ability to interact with a multidisciplinary team of medicinal chemists, biologists, pharmacologists and external collaborators;
• Familiar with modeling and simulation is a plus;
• Bilingual in English and Chinese is required.

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。