Manager, Clinical Research
Core
Lead clinical development programs in China for hematology assets, ensuring data quality and regulatory submission readiness.
Role type
Senior IC clinical scientist (hematology)
Builds
Clinical study protocols, medical monitoring reports, regulatory dossiers, and publication manuscripts for new drug assets.
Domain
Biopharma / Hematology / China regulatory environment
Required skills
Clinical development, Medical monitoring, Protocol development, Regulatory dossier preparation, Clinical trial planning, Adverse event review, Scientific writing, KOL engagement, Data review, GCP compliance
Preferred skills
Hematology postgraduate training, China regulatory expertise, Medical writing experience
Technologies
Clinical trial management systems, Regulatory submission platforms
Responsibilities
Develop clinical study protocols and plans, conduct medical monitoring to ensure data quality, draft study reports and regulatory dossiers, engage key opinion leaders, review serious adverse events, prepare manuscripts for publication, provide scientific inputs for regulatory reviews.
Seniority
Senior, hands-on IC
