Physician II (Cell Therapy)
Core
Lead medical monitoring and clinical study delivery for cell therapy/immunology/oncology projects in China, serving as the clinical science expert for regulatory filings and interactions.
Role type
Senior Clinical Science Physician (Cell Therapy)
Builds
Clinical study deliverables, regulatory submissions, and China development strategies for cell therapy compounds.
Domain
Biopharma, Cell Therapy, Immunology, Oncology
Deliverable
client delivery
Required skills
Medical monitoring, protocol design, safety signal evaluation, regulatory interaction, data analysis (CSR/CSP), strategic planning, KOL engagement
Preferred skills
Therapeutic area expertise in cell therapy/immunology/oncology, compound knowledge, understanding of regulatory guidance
Technologies
None stated
Responsibilities
Ensure integrity of clinical studies, co-own study delivery with operations, develop study documents (protocol, CSR), analyze study results, form advisory boards, liaise with safety physicians and pharmacologists, prepare protocols for review, set strategic direction for regulatory submissions, consult on protocol design, support BD/marketing activities
Seniority
Senior, hands-on IC