ConsignMed, a Niche Clinical Staffing Company since 2003, and rated by Diversity Business as one of the fastest growing companies in the US is seeking a Clinical Director.
Provide strategic oversight of all Company Neurovascular Sponsored Research and Investigator Initiated Studies in compliance with relevant local, national, and international clinical trial regulations and guidelines and in accordance with divisional strategic needs. Position will be specifically responsible to facilitate the strategy, planning, development, and analysis of clinical studies including cross-regional coordination and implementation of worldwide clinical and product approval strategies.
• Works collaboratively to drive and develop global clinical trial strategies across multiple therapeutic franchise product lines.
• Ensures clinical trials are designed and executed in compliance with all global regulations and are consistent with global business objectives.
• Oversees the on-time, on-budget execution of clinical programs and advances all projects simultaneously.
• Participates in internal and external audits. Is expected to be the subject matter expert on clinical trial activities in concert with the clinical franchise program manager (therapeutic lead).
• Guides clinical program managers in the development of realistic clinical trial budgets, project schedules, and trial management. Allocates/re-allocates internal and external resources to projects, as needed.
• Directs research teams in accordance with project plans and performance standards.
• Coaches, mentors, and teaches others the appropriate application of laws and standards in the areas of clinical trial design, compliance, and ethical conduct of research trials.
• Conducts briefings and technical meetings as needed. Analyzes and presents data from external/internal sources and partners with other functions such as Regulatory Affairs to obtain regulatory product approvals and/or ensures program managers are adequately prepared to handle briefings and technical meetings.
• Interacts with and/or drives clinical trial discussions with regulatory agencies as needed and/or ensures program managers are prepared for such discussions.
• Provides direction for resolution of complex issues concerning the management of investigational site activities, safety, ethics, and physician relationships.
• Assumes responsibility for and execution of any other duties assigned by Manager to support division or function needs.
• Masters-level degree required preferably in a science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences).
• Degree in business management preferred. Proficiency in resource planning and financial management (clinical trial budgeting) required.
• 10+ years clinical research experience (device, pharmaceutical, biotechnology), including at least 5 years in a managerial capacity managing projects and clinical professionals in a product development setting.
• International clinical research experience required; expatriate research work experience preferred.
• Previous trial design negotiation experience with FDA or other regulatory body required; IDE to PMA submission and approval experience preferred.