Provide scientific leadership and oversee global clinical studies for Lutonix Technology Center.
Summary of Position with General Responsibilities:
• Coordinate and execute global clinical strategies ensuring compliance with regulations and good clinical practice:
- Clinical Trial Design
- Trial management and execution
- Data analysis
• Lead publication strategy.
• Lead efforts to choose investigators and clinical sites.
• Oversee contract negotiations with clinical sites, consultants, research organizations and database management firms.
• Take a leadership role interfacing with FDA in support of regulatory submissions.
• Author clinical section of regulatory documents and responses to regulatory agencies.
• Serve as a member of Lutonix Management Team.
• Make presentations to Senior Management and Regulatory Bodies (FDA.)
• Oversight of all biostatistical analysis, data management, and production of study reports.
• Manage clinical personnel.
• Minimum 15 years experience in industry, some in a clinical department.
• Has directly led human clinical trials.
• Experience in working with the FDA to gain both IDE/IND and PMA approvals.
Additional Desirable Qualifications Skills and Knowledge:
• Publication experience preferred.
• Competence in biostatistics
Education and/or Experience:
Bachelor’s degree in life science required; advanced degree in biological or medical/clinical sciences preferred.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...