The Chief Medical Officer reports to the Chief Executive Officer and is a key member of the Executive Team, engaged in defining the overall clinical development strategy, product labeling and direction of the organization. The CMO provides clinical oversight, expertise, and leadership to ensure the delivery of affordable, quality, and a risk adjusted clinical development program. The Chief Medical Officer's responsibilities include the strategy, development, and implementation of innovative clinical programs, including collaborating with strategic business partners, US FDA, and directing the organization toward its primary objectives.
Essential duties of the CMO include:
• Serve as an information resource to the CEO, Board of Directors, and Investors
• Serve as the organization's VP Regulatory & Product Development
• Serve as a liaison to the US Food and Drug Administration, broader medical community, Contract Development and Manufacturing Organizations, Contract Research Organizations, including hospitals, and research institutions.
• Develop clinical leaders; recruit, retain, and supervise and evaluate clinical staff and contractors
This is a fast pace project for a 505(b)2 regulatory submission and clinical development program.