Senior Medical Director

Senior Medical Director

Job responsibility:

• Lead clinical development. Provide clinical as well as general medical expertise throughout developments, from clinical development plan, protocol development through study conduct, regulatory submission(s) and product launch.
• Provide expert input to the clinical studies and provide oversight of protocol development, in collaboration with partner’s global teams
• Responsible for protocols to identify region-specific operational issues for the territory. Where necessary, provide medical oversight of clinical projects
• Perform as medical monitor or oversight for CRO partners on medical queries and issues
• Provide medical expertise in interactions with regulatory agencies
• Attend investigator meetings; deliver clinical presentations as needed
• Oversight vendors as needed to ensure successful clinical studies for regulatory submission goal
• Proactively identify key investigators in the region and cultivate long-term collaborations. Recruit and manage regional Clinical Advisory Board if needed
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community

Qualification

• Medical Doctor degree or Master degree of relevant therapeutic area
• At least 3-5 years of clinical development or pharmaceutical medical function experience
• Previous experiences in IND/NDA submission and interacting with regulatory authorities preferred
• Good communication skills and presentation skills
• Fluent English in written and verbal