上海招聘

1. Support clinical development and regulatory filing activities by applying pharmacokinetic and pharmacodynamic data acquired at various development stage
2. Ensure High quality contribution to development strategies together with China and global project teams for product development and registration.
3. Define PK, PK/PD, BE requirements in all development projects in accordance with the CFDA and FDA requirement high quality, timely, efficient, scientific inputs to lead protocol writing/site selection/CRO selection/ data analysis/ reports
4. Prepare, compile and review appropriate sections of CTA dossiers/NDA documents and submission dossier to the regulators
5. Identify laboratory for new assay and ensure technology transfer to China in collaboration with Bioanalysis department as needed
6. Represent the PK/PD discipline and ensure high quality interactions with various health authorities, external investigators and internal stakeholders
7. Represent the company in the engagment with external CRO ensuring successful design, planning, and delivery of PK trials.
8. Play key role in the review and interpretation of PK data. Through the in-depth understanding of the PK profile, able to advise and enable the clinical them to design the next phase of clinical trial.
9. Able to design and develop plan for early PK/PD strategy for new assets.

1. Master or above in PK or related major. ·
2. At least 2-years of related experience ·
3. Knowledge of drug development process including in vitro/in vivo study in drug discovery and development ·
4. Knowledge of pharmacokinetics and pharmacology concepts, and experience with PK/PD data analyses, i.e. population and exposure-response analyses ·
5. Knowledge of bioanalytical methods ·
6. Strong English and Chinese communication in both oral and written ·
7. Excellent skills of Word, Excel, PowerPoint and Outlook ·
8. Ability to work in a matrix, project-oriented environment ·
9. Ability to organize and work simultaneously on multiple projects ·
10. Performance driven and ability to deliver result under pressure

瑞石生物医药有限公司于2018年1月创立，总部位于中国上海，在北京及美国波士顿设有分支机构，是一家创新的研发驱动型全球生物制药公司，立足于开发临床急需的创新药物以满足患者的需求。目前，瑞石专注于自身免疫类疾病创新药物的全球开发，一方面与国内领先的制药企业恒瑞合作将中国创新药物引入美国及欧洲，助力中国创新走向世界；另一方面还借助公司管理团队在中国开展创新药物研发的丰富经验，积极引进国际领先的创新药物解决中国患者的临床需求。