Late Phase Clinical Trial Medical Director

The Medical Director will continue to develop and lead an existing comprehensive late phase clinical trial program across FCS. The medical director will partner with investigators to provide education and ensure compliance with SOPs, Good Clinical Practice standards and applicable laws and regulations.

Primary Key Performance Areas

KPA 1 – Research Planning

• Collaborate with the Director of Drug Development, CMO for Therapeutics and Analytics,  President/Managing Physician and senior research leadership team to continue to develop the overall research strategy.
• Maintain disease focused physicians to serve as content experts in appropriate trial selection ensuring access to a comprehensive, clinically relevant trial portfolio driving increased trial access for patients. 
• Establish a data driven clinical trial scientific and feasibility review process in collaboration with physician disease focused experts and research leadership.
• Establish and maintain critical relationships with industry partners.

KPA 2 – Growth & Development.

• Maintain thorough and up-do-date knowledge of treatment and research and serve as research conduct expert for physician investigators.
• Oversee, encourage, facilitate, and maximize enrollment on late phase trials across sites.
• Ensure appropriate education and mentorship to investigators and their staff to facilitate appropriate enrollment.
• Serve as Principal Investigator on Clinical Trials as requested, in accordance with the requirements set forth FDA Form 1572, policies and procedures and applicable law
• Ensure that late phase clinical research efforts reflect the health disparities and needs of the patients across the practice.

KPA 3 – Regulatory and Reporting

• Direct and interact with internal and external regulatory personnel to assure compliance with regulatory requirements for clinical trials.
• Partners with physician investigators to ensure protocol compliance, issue resolution, deviation investigation, audit/inspection preparation, or other assistance as needed.
• Report results of trials, through manuscripts in peer reviewed medical journals, through presentations at local and national professional meetings, and otherwise as appropriate
• Act in accordance with the FCS Code of Conduct and Mission and Values Statement.
• Performs other duties and projects as assigned.

Previous Experience:

• Experience with Oncology clinical research
• Published in peer reviewed journals and significant speaking experience
• Has served in a primary leadership role in numerous clinical trials