Clinician, Senior Manager
Core
Ensure medical and scientific integrity of clinical trials, oversee safety of participants, and drive operational excellence in study execution.
Role type
Senior Manager, Clinician (Clinical Development)
Builds
Clinical trial protocols, safety reports, and regulatory submissions for biopharmaceutical products
Domain
Biopharmaceuticals, Clinical Development, Regulatory Affairs
Required skills
Clinical trial design, protocol authoring, medical monitoring, safety signal review, regulatory compliance (ICH-GCP), data interpretation, stakeholder engagement
Preferred skills
Drug development experience, project management, cross-functional leadership, China-specific development strategy
Technologies
Clinical trial management systems, statistical analysis packages, regulatory submission platforms
Responsibilities
Contribute to protocol design and development, provide medical oversight for clinical studies, review adverse events and safety data, serve as primary medical contact for investigators, support Data Monitoring Committees, prepare regulatory submissions (CTA/NDA)
Seniority
Senior Manager, hands-on IC with leadership scope