Medical Director - Clinical Development & Research

Novo Nordisk

Full-time - Senior

10,001+ employees

Merchant Wholesalers, Nondurable Goods

About the position

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.

Responsibilities

• Provide regional medical & scientific input to regional evidence generation planning and project strategic documents.
• Provide regional medical & scientific input on trial outlines, trial protocols, and informed consent forms (ICF).
• Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings.
• Review medical monitoring plans and conduct monitoring activities as per the plan.
• Manage all required local protocol amendments and deviations.
• Assure timely initiation of studies and act as a liaison with Regulatory, project teams, and investigators.
• Write and/or review clinical sections of clinical trial reports, statistical reports, and investigator's brochures.
• Provide medical and scientific input to advisory committee hearings and labelling.
• Stay abreast of guidelines, current trends, and medical practices in the assigned therapeutic area.
• Assist in developing clinical program timelines, budgets, and strategies.

Requirements

• M.D. required; PhD is ideal but not required.
• A minimum of 6 years relevant experience required, with academic research or pharmaceutical development experience preferred.
• Board certification or relevant therapeutic area experience in diabetes, cardiovascular, or obesity required.
• Prior clinical research or related experience, including monitoring of clinical studies and knowledge of drug development phases.
• Strong leadership skills and project management skills are essential.
• Effective communication and presentation skills are necessary.
• A strong collaborative mindset is required.

Nice-to-haves

• Experience in Health Economics and Outcomes Research (HEOR) studies.
• Familiarity with regulatory guidelines and directives.

Benefits

• Competitive salary and performance bonuses.
• Comprehensive health insurance coverage.
• 401(k) retirement savings plan with company matching contributions.
• Paid time off and holidays.
• Opportunities for continued education and professional development.