Director, Clinical Affairs

$196,600 - $245,700/Yr

Terumo - Lakewood, CO

Full-time - Senior

Remote - Lakewood, CO

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Director of Clinical Affairs at Terumo Blood and Cell Technologies is responsible for setting clinical strategies for various business area projects. This role involves developing objectives, plans, and protocols for clinical trials to support the organization's business strategies and goals. The director will oversee clinical trials, manage the Clinical Advisory Board, and ensure compliance with regulatory requirements while fostering a culture of quality and compliance within the organization.

Responsibilities

• Provide strategic direction and operational leadership for the clinical affairs team and business.
• Develop and communicate effective clinical strategies to meet established business goals.
• Ensure a culture of quality and compliance exists in the business area or region.
• Lead and approve the development of clinical strategy to support product claims and regulatory strategy.
• Supervise clinical staff and build relationships with principal investigators and vendors for clinical activities.
• Oversee the establishment and maintenance of global procedures for conducting clinical trials and studies.
• Direct the professional growth of staff through guidance, training, and supervision.
• Collaborate with senior colleagues to resolve complex issues.
• Ensure clinical study proposals meet regulatory requirements and company SOPs.
• Negotiate clinical research organization agreements and oversee clinical site selection.
• Resolve customer complaints related to clinical trials and oversee clinical evaluation reports.
• Develop, monitor, and report metrics to improve trial performance.
• Lead Clinical Advisory Boards and bring in subject matter experts as needed.
• Foster relationships with Regulatory Affairs, R&D, Scientific, Quality, Legal, Manufacturing, and Marketing colleagues.
• Plan, coordinate, monitor, and report on clinical studies conducted for the business.
• Prepare clinical reports/documentation for regulatory submissions and publications.
• Review and approve study reports to ensure objectives are met and results are valid.
• Develop and maintain the department budget.

Requirements

• Four-year Bachelor of Science in nursing, medicine, biological sciences, or related scientific or medical discipline required.
• Advanced degree (PhD, MD) in medicine, nursing, biological sciences, or related scientific or medical discipline preferred.
• Minimum of 10 years clinical experience in the medical device or pharmaceutical industry conducting clinical trials required.
• Minimum 5 years managerial experience with multiple direct reports.
• Extensive experience in managing all phases of multi-center clinical trials for medical devices, diagnostics, or pharmaceuticals required.
• Knowledge of medical statistics and experimental design.

Nice-to-haves

• International clinical trial experience is a plus.

Benefits

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Pet insurance
• Vision insurance
• Wellness program