Director of Research

Reports to the Vice President of Research and Development Biomedical Company producing and selling implants and instrumentation for craniomaxillofacial and thoracic hard tissue fixation. The primary responsibility for this position is to design and manage pre-clinical and clinical studies to support development, regulatory approval, and post-market surveillance of innovative new products that anticipate the needs of our customers.  This responsibility includes:  preparation and management of the annual research budget, design of study protocols, preparation and negotiation of research contracts, management of compliance to study milestones, evaluation and analysis of study results, and assisting with regulatory document preparation and management of clinical research organizations. The secondary responsibilities for this position include:  management of wet lab facilities, chairing monthly Research Committee meetings with upper management, and management/development of one direct report (administrative assistant).

Background Required:
• Pre-clinical and clinical research experience (5 years minimum)
• Statistical analysis Experience, Study Evaluations
• Involvement in one clinical trial to support a PMA/IDE submission to FDA
• Travel: 20%
• Location:  Jacksonville, Fl (relocation asst)
• Education: Bachelors Degree in Engineering, Biomedical, Biochemistry, or Public Health – Epidemiology disciplines

Background Preferred (but not required):
• Knowledge of ISO 13485 requirements
• Medical Device Manufacturing Knowledge / Background
• Prior OR / Surgical Suite Interaction
• Education: MS Engineering Discipline, Biomedical, Biochemistry, or Public Health – Epidemiology disciplines
 
Other Essential Abilities and Skills:
• Excellent Problem Solving Skills, Conflict Resolution
• Strong interpersonal skills
• Business acumen, strategic thinker
• High energy & persistent, results oriented
• Excellent Communication Skills (verbal, written, presentation)