Novo Nordisk
posted 2 months ago
The Medical Director for Clinical Development & Research at Novo Nordisk plays a pivotal role in the Clinical, Medical and Regulatory (CMR) department, which is recognized for its diversity and collaborative spirit. This position is centered around utilizing medical and clinical expertise to design, implement, and monitor clinical studies across all phases, from Phase 1 to Phase 4. The Medical Director will provide essential medical and scientific support for various company activities within the assigned therapeutic area, ensuring that patient needs are at the forefront of all initiatives. In this role, the Medical Director will engage in evidence generation planning, contributing regional medical and scientific input to strategic documents such as Evidence Generation Plans and Product Development Plans. The position also involves clinical study management, where the Medical Director will provide input on trial outlines, protocols, and feasibility assessments, as well as manage local protocol amendments and deviations. The role requires active participation in the recruitment of investigators and providing necessary training to ensure the timely initiation of studies. Additionally, the Medical Director will serve as a regulatory liaison, responsible for writing and reviewing clinical sections of trial reports and responding to regulatory inquiries. Staying updated on current trends and medical practices in the therapeutic area is crucial, as the Medical Director will represent Novo Nordisk in various external meetings and provide input for Health Economics and Outcomes Research (HEOR) studies. The position demands strong project management skills, effective communication, and a collaborative mindset to work seamlessly across different skill areas within the organization.