Key Responsibilities：
1、Provide medical leadership and strategic oversight for oncology clinical development programs, particularly Phase 3 studies and registrational trials.
2、Lead or support the design, execution, and interpretation of global MRCTs, ensuring alignment with regulatory requirements and scientific goals.
3、Serve as the clinical point of contact for cross-functional teams, external partners, and regulatory agencies (e.g., FDA, EMA, NMPA).
4、Drive development of clinical sections for NDA/BLA submissions and participate in interactions with global health authorities.
5、Contribute to development of regulatory strategies including those supporting accelerated approval pathways (e.g., single-arm registration trials, Breakthrough Therapy Designation [BTD], Orphan Drug Designation [ODD]).
6、Collaborate closely with regulatory affairs, clinical operations, biostatistics, medical writing, and safety to ensure high-quality clinical program delivery.
7、Interpret and communicate complex clinical data internally and externally, including support of product labeling discussions and launch activities.
8、Provide medical and scientific leadership in rare cancer indications and/or tumor-agnostic development strategies when applicable.
9、Contribute to company strategy and decision-making on product development, lifecycle management, and indication expansion.
Qualifications
Required:
1、M.D. (or equivalent medical degree) with valid clinical training and at least 3 years of physician practice experience.
2、Hands-on experience in Phase 3 clinical trials in oncology.
3、Direct involvement in NDA/BLA submissions and successful regulatory interactions.
4、Experience with MRCTs and global development.
5、Demonstrated knowledge of FDA, EMA, NMPA, or other regulatory authority requirements and processes.