锦鲤求职岗位描述
Responsibilities：
• Provide medical and scientific leadership to clinical development teams.
• Contribute to clinical development and registration strategy for diverse pipelines in China and global markets.
• Provide overall medical and safety oversight of oncology clinical trials as assigned.
• Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment.
• Contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents.
• Prepare materials for investigator meetings, participate and present in investigator meetings.
• Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures.
• Assist with data safety monitoring board activities.
• Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriate.
Qualification：
• Graduate of an accredited medical school with at least eight years of clinical development experience. Experience in early phase oncology or autoimmune development preferred.
• Experience writing clinical development protocols, IB and study reports preferred.
• Experience with medical and safety monitoring.
• Fluent in written and verbal English.
• Proactive and organized with exceptional follow-up.
• Anticipate/ identify problems and takes appropriate action to correct.
• High degree of accuracy with attention to details.
• Willing and able to learn quickly in a fast-paced environment.
• Excellent team player and leadership.