Your new role
• Lead the development of clinical development strategy and plan based on the registration strategy and ensure excellent implementation
• Be accountable for all clinical deliverables (e.g., clinical study protocol, clinical study reports and submission summary/HA response document)
• Closely collaborate with KOLs and maintain academic relationship with team
• Lead the clinical development for the assigned compounds or products in China
• Deeply understand global clinical development strategy and plan. Ensure the clinical development plan fully aligned with China and globally. Keep the China clinical development plan updated. Be responsible for the clinical project planning
• Work closely with headquarter product development team and regional RA team on CDE consultation meeting
• Propose clinical study design and develop clinical study protocol based on the clinical development plan. Be accountable for all clinical deliverables (e.g. clinical study reports and submission summary/HA consultation & response document) if applicable Ensure the medical and scientific sound and fully meet HA requirements for the compound registration.
What you'll need to succeed
• A M.D or Ph.D. degree of clinical, biomedical, pharmacy, biology or equivalents with drug development experience is required.
• At least 5 years in drug development of MNC company
• Knowledge of clinical development process and HA (especially NMPA) requirements
• Familiar with cancer biology and drug development process; oncology therapeutic area expertise strongly preferred
• Fluent in written and verbal English
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1238533