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For our client, a dynamic international biotechnology company focused on clinical-stage development, we recruit a: Senior/Executive Medical Director - Clinical Developement ...
Job Responsibility:
Lead Clinical Development: Provide clinical and general medical expertise throughout the entire development process, ranging from the clinical development plan and protocol development to study conduct, regulatory submission(s), and product launch
Protocol Oversight: Provide expert input to clinical studies and oversee protocol development in collaboration with the partner’s global teams
Regional Strategy: Take responsibility for protocols to identify region-specific operational issues for the territory and provide medical oversight of clinical projects where necessary
CRO Management: Act as the medical monitor or provide oversight for CRO partners regarding medical queries and issues
Regulatory Interaction: Provide medical expertise during interactions with regulatory agencies
Vendor Oversight: Oversee vendors as needed to ensure clinical studies successfully meet regulatory submission goals
External Engagement: Attend investigator meetings and deliver clinical presentations as needed. Proactively identify key investigators in the region to cultivate long-term collaborations, and recruit/manage a regional Clinical Advisory Board if needed
Relationship Building: Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community
Requirements:
Medical Doctor degree or Master degree in a relevant therapeutic area
At least 5-10 years of experience in clinical development or a pharmaceutical medical function
Previous experience in IND/NDA submission and interacting with regulatory authorities is preferred