| The Medical Director, Medical Affairs will provide medical review for promotional and other marketing programs and serve as a point person for Phase IV study operational support and drive publication efforts for marketed products. ESSENTIAL FUNCTIONS: · Liaise with the Global and Local Marketing teams to develop the strategic planning for Phase IV studies and publications, both organic and investigator sponsored trials for all products. · Guarantee alignment with the supporting areas within Regulatory, Safety, and R&D for resource optimization with timely implementation of Phase IV clinical trials and publication of results for all products. · Design, establish, and maintain a matrix to effectively accomplish Clinical Research and Global Marketing organization's goals and objectives within the function, for all products, in relationship to publications and mining of internal data. · Participate in design, development, review, monitoring and approval of Phase IV clinical trial protocols, clinical trial reports, registry, and publications for all products. · Liaise and manage relationships with key investigative leaders and contract research organizations or other external vendors needed for the execution of Phase IV clinical trials and publications for all products. · Provide medical input into Promotional Advertising Review Committee for all promotional and external materials. Assure medical accuracy of all materials with particular emphasis on background materials as they relate to quotes from medical literature. · Ensure that all activities are in compliance with ICH and other international regulatory guidelines and follow relevant GCPs and SOPs. Support Regulatory and Safety analyses for all products. EDUCATION REQUIREMENTS: PhD, PharmD , MD or DO KNOWLEDGE AND SKILL REQUIREMENTS · 5+ years clinical experience in a biotech or pharmaceutical company. · 3+ years experience with a Phase IV/Publication focus ideally in Medical Affairs/ Medical Marketing. · Impressive technical/scientific credentials must be complemented by a strategic and results-oriented approach to drug development, proven ability to develop productive relationships with thought leaders, FDA contacts and other critical stakeholders, and sound operational judgment. Company is flexible regarding therapeutic area. · Experience with later stage development with demonstrated success as both a strategist and a tactician. · Proficiency in MS Office, experience with SAS and other research databases would be a plus · "Make things happen" leadership style · Astute business instincts · Impressive, consistent and recent track record of success and achievement. PREFERRED EDUCATION, SKILLS, AND EXPERIENCE: MD, DO, with MBA CB* BSP~ |