Director, Clinical Affairs

$245,700 - $245,700/Yr

Terumo BCT - 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 across all 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, national validation studies, post-market surveillance, and hemovigilance studies, while managing the Clinical Advisory Board (CAB) for the organization.

Responsibilities

• Provides strategic direction and operational leadership for clinical affairs team and business.
• Develops and communicates effective clinical strategies to meet established business goals.
• Ensures a robust culture of quality and compliance exists in the business area or region.
• Leads and approves development of clinical strategy to support product claims and regulatory strategy.
• Supervises clinical staff and builds relationships with principal investigators and vendors for clinical activities.
• Participates on Management Teams for business areas.
• Oversees establishment and maintenance of global procedures for conducting clinical trials in accordance with standardized operating procedures.
• Directs professional growth of staff through guidance, training, and supervision.
• Works closely with senior colleagues to resolve complex issues.
• Ensures clinical study proposals meet regulatory requirements and business goals.
• Directs activities related to negotiating clinical research organization agreements and clinical site selection.
• Resolves customer complaints related to clinical trials and oversees preparation of clinical evaluation reports.
• Develops, monitors, and reports metrics to improve trial performance.
• Leads Clinical Advisory Boards and brings in subject matter experts as needed.
• Fosters relationships with Regulatory Affairs, R&D, Scientific, Quality, Legal, Manufacturing, and Marketing colleagues.
• Leads external groups participating in clinical trials, including clinical research organizations and data safety monitoring boards.
• Plans, coordinates, monitors, and reports on clinical studies conducted for the business.
• Oversees preparation of clinical reports for regulatory submissions and publications.
• Reviews and approves study reports to ensure objectives are met and results are valid.
• Develops, prepares, and maintains 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.
• International clinical trial experience is a plus.
• Extensive knowledge of clinical trial reporting and regulatory requirements.
• Thorough knowledge of physiology and clinical practice of relevant therapies.
• Knowledge of medical statistics and experimental design.
• Broad knowledge of clinical methods related to laboratory and therapy delivery.
• Extensive knowledge of clinical study (GCP) and regulatory requirements.
• In-depth technical knowledge of international medical device regulations and standards.
• Ability to solve practical problems and communicate complex clinical requirements effectively.
• Demonstrated ability to lead, motivate, and develop clinical skills in associates.
• Excellent written and oral communication skills.

Nice-to-haves

• Experience in representing the business during collaboration meetings with regulatory authorities.
• Advanced presentation and communication skills.

Benefits

• Multiple group medical, dental, and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, and pet insurance.
• 401(k) plan with matching contribution.
• Vacation and sick time programs.