Director of Clinical Research BHJOB1778_220

The Wellington Group is seeking an experienced Clinical Operations professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market through developing a quality clinical program!

The Director of Clinical Affairs is a key management position in the development, research and commercialization of new products. The Director will develop, implement and manage the company’s clinical research strategy.

Responsibilities include:
• Design and direct the company’s global clinical study strategy to obtain timely regulatory approval of products and acceptance by clinicians
• Lead the design of credible clinical studies, integrating inputs from clinical study professionals, clinicians, statisticians, regulatory agencies, and management
• Manage contracted Clinical Research and Core Lab staff and other consultants to prepare materials, engage clinicians, conduct studies, compile data, and produce reports on schedule and within budgets
• Develop relationships with participating clinicians and clinical research staff to assure effective management and communications
• Lead the preparation of the clinical portion of regulatory submissions
• Represent the company’s clinical perspective in regulatory agency interactions
• Inform senior management of clinical study status and issues
• Participate in publication of clinical results

The qualified candidate will have:
• 10+ years working in clinical study programs in the medical products industry, including at least 4 years managing design and successful completion of clinical studies for device/drug combination products
• Demonstrated effectiveness in managing and motivating Clinical Research Organizations
• Significant role in directing participating clinicians
• Knowledge of international clinical regulatory requirements
• Strong planning, communication, and management skills
• Preparation of clinical publications
• BS/MS in life sciences with training in clinical research
• Frequent international travel

Industry: Medical Devices, Biologics, Pharmaceutical

Location: Either RTP, NC or Cambridge, MA

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)