职责描述：
1. Build and manage a high-performance Clinical Science team, enable CARsgen global clinical development program implementation.
2. Generate and develop the overall medical strategy to support clinical development activities.
3. Deliver timely and high-quality implementation of clinical development strategies and lead the IND or NDA submissions of new products in China.
4. Ensure effective design and review of study protocols, study enrollment, data analysis/interpretation, and provide clinical support to regulatory process.
5. Work closely with Regulatory Affairs and Early Discovery to provide scientific input on unmet medical needs assessment and to ensure an optimal local registration strategy for new products.
6. Play a key role in developing, fostering relationships, and conducting medical communications with KOLs, academic institutions and government departments.
7. Constantly track and keep updated on clinical research related laws and regulations to ensure study with no compliance issue.
8. Can act as a Medical Monitor, evaluating and managing safety issues on ongoing studies. Provide medical insight in analyzing and interpreting data, and interact with investigators and key opinion leaders.
9. Work in conjunction with Pharmacovigilance to ensure timely reporting of safety signals to internal and external customers e.g. regulatory authorities.
10. Work with experts in pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics, drug safety, translational and regulatory strategy to generate robust and flowless clinical development plans, target product profiles, protocols and study reports.
11. Assist in the development of case report forms used to capture data from clinical protocols.
12. Responsible for the department budgeting, objective setting, and performance management.
13. Accountable for the expected deliverables and outcomes of the department in accordance with business and projects requirements.
14. Continually and proactively provide recommendations to improve and enhance the work efficiency of Clinical Science team.
任职要求：
1. MD degree with advanced scientific training/experience in Hematology.
2. 10+ years of working experience including 5+ years of people management in pharmaceutical or biotechnology industry.
3. Experience of protocol design and clinical trial implementation in phase I-III in oncology area are preferred.
4. Therapeutic area knowledge in oncology, especially in hematology and cellular immunology, or an oncologist is preferred.
5. First-hand experience in immunotherapy, cell therapy, and/or gene therapy is a plus.
6. International clinical research or medical team experience would be a plus.
7. Knowledge of GCP, NMPA regulations and guidelines.
8. Capability for strategic thinking and planning, and hands-on experiences.
9. Demonstrate the ability to organize, plan and prioritize the multiple projects.
10. Demonstrate the ability to analyze complex situations and proactively identify opportunities/issues, and effectively solve problems that is cross functional.
11. Previous experience of interacting with regional and national health authorities is desirable.
12. Display the highest level of integrity that is aligned with CARsgen value.
13. Proficient in English and Chinese, strong verbal and written skills.

其他信息
语言要求：英语