RESPONSIBILITY   

• Leads the development of clinical research strategy of pipeline products for Greater China region in partnership with multiple external partners and relevant internal cross functional team members.
• Responsible for medical content of relevant study documents, including protocol, ICF, CSR, academic communications and publications.
• Execute and provide support to medical activities relevant to Phase I-III clinical trials, including medical monitoring, DSMB meeting, CDE communication and others.
• Establish and maintain strong academic relationships with key external stakeholders (eg, scientific advisors, consultants, researchers, regulatory officials, KOLs, health care professional societies, etc.)
• Develops motivated clinical research team with motivation and result-oriented culture.
• Support regulatory filing and study operations where medical expertise is required.

REQUIREMENT   

• Minimum requirement is MD. (Master or PhD or other postgraduate degree in oncology field is preferred).
• Minimum 15 years working experience in clinical develop function of MNC and biotechnology pharmaceutical companies.
• Good track record in strategic planning and implementation of key clinical research activities.
• Familiar with NMPA, FDA and EMA guidelines and IND/NDA processes.
• Experienced team leader with good leadership skill and project management.
• Excellent communication skills.
• Fluent English in oral, reading and writing required.