Description

The Director, Medical Affairs is responsible for all medical support of the Orthopedic Business Unit of this pharmaceutical company. This includes designing and managing the processes related to the acquisition, organization, analysis, efficacy, and safety interpretation, reporting and presentation of clinical and non-clinical data within the drug development process and for the support of marketing and sales efforts. This position supports the critical interface between scientific and commercial communities within the company and plays a pivotal role in Phase III-IV clinical trials, product development programs and all relevant FDA submissions for new product claims. The incumbent reports to the Vice President of Medical Affairs.

Duties
• Leadership of Orthopedic Medical Affairs
• Design, develop and manage clinical and non-clinical studies
• Manage the clinical and non-clinical study analysis process according to protocol and additionally explore/recognize/pursue trends in the data
• Interpret clinical and non-clinical study data in the context of existing literature and write/publish results
• Periodic and annual drug safety reporting
• Compile published an in-house data for descriptive and teaching presentations
• Contribute/develop topics for quarterly Medical Affairs/Sales Training purposes
• Participate in multidisciplinary projects designed to support the commercialization of the company's products
• Create relationships with the medical community that support the scientific and marketing efforts of the company

Qualifications
• M.D. with 1-3 years of pharmaceuticals industry, or related experience including clinical project management, preferably in the area of orthopedics
• Clinical and scientific report writing expertise and peer reviewed publications demonstrating the ability to organize, analyze and interpret clinical and scientific data
• Experience in product planning and development involving publication strategies, product monographs, promotional materials; DDMAC interactions is a definite plus
• Ability to develop medical/scientific data into clear, cogent vignettes, teaching programs and plenary presentations
• Commitment to provide leadership by example