Director, Medical Affairs

Director of Medical AffairsKelly Clinical Research has an immediate direct hire opening for a Director of Medical Affairs. Our client is a leader in the biopharmaceutical industry. The position is located in the Greensboro/High Point, NC area. North Carolina is an incredible place to live with scenic mountain ranges and an amazing coastline. http://www.welcomewinstonsalem.com/ http://www.greensboro-nc.gov/visitors/ http://www.visitnc.com/ http://www.biltmore.com/visit/house/default.asp http://www.outerbanks.org/index.aspResponsibilities:1) Participate in formulating overall clinical strategy.2) Serve as Principal Investigator for selected trials.3) Communicate and interact effectively with in-house personnel to ensure timely and effective designing, execution, safety monitoring and report of ongoing trials.4) Provide medical leadership, supervise teams within the Medical and Clinic Departments (e.g. Pharmacy), as well as other site Sub-Investigators.5) Assist with protocol feasibility assessment and proposal set up as needed. 6) Participate in the review and approval of clinical trial synopses, protocols, and other study related documentation.7) Provide medical monitoring functions for all active protocols.8) Be involved with pharmacovigilance activities and review adverse event reports and PSUR documents and final study reports9) Be involved in safety review meetings and dose escalation discussions as required. 10) Sign off on queries and e CRF as needed. 11) Actively involved in the management of the subjects care and well being in the clinical trial. 12) Develop relationships with other Investigators, and Key Opinion Leaders.13) Interact with regulatory agencies, as appropriate. 14) Participate in developing Medical Directives for the site, and their implementation into practice.Requirements:1) MD (Ph. D. a plus)/BC/BE Internal Medicine or any other relevant field2) 2+ years of clinical research experience in the biotech/pharmaceutical industry3) Working knowledge of ICH-GCP and FDA regulatory requirements4) Excellent written and oral communication and presentation skills5) Superb analytical and organizational skills6) Ability to multi-taskKelly Clinical Research connects clinical research professionals with opportunities to advance their careers. To be immediately considered for this great opportunity, click 'Apply Now!' Learn more about company