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Main responsibilities:
1. Good understanding of the drug development process with experience managing data, writing clinical pharmacology/pharmacokinetic reports and regulatory submissions2. Conducts clinical pharmacology studies in line with product development strategies, insure working process following regulatory requirement and scientifically sensible
3. Assists with managing timelines and budgets to ensure efficient execution of clinical pharmacology studies and early phase trials
4. Perform and assist PKPD analysis for understanding of PKPD relationship for drug effect and dose selection
5. Participate in project meeting, and actively involved in data analysis, study preparation for the update and issue solving
Basic Qualifications
1. Ph.D. or Pharm.D in pharmacokinetics, pharmaceutical sciences, or related discipline or Master with strong background, who has extensive experience in the pharmaceutical/biotech industry in clinical pharmacokinetics or a related discipline
2. Solid knowledge of clinical pharmacokinetic concepts and extensive working experience of clinical pharmacology programs and analysis software along with PK modeling
3. Excellent written and oral communication, interpersonal and problem solving skills
4. Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines
5. Hands-on experience in physiologically-based PK modeling and population PK analysis, or detailed knowledge of PK software (e.g. WinNonlin, Simcyp, NLME, NONMEM, etc.) is plus
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.
迪哲医药,于2017年10月独立运营,是一家研发驱动型生物医药企业,致力于全球创新药物(First-in-class/ Best-in-class)探索、研发以及商业化。
迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心,设立于中国上海,是阿斯利康全球四个研发中心之一(另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡);是国际一流、高产出的创新药研发机构,拥有全球领先的转化医学和新药分子设计与筛选技术平台;在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。