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 all business area projects, developing objectives, plans, and protocols for clinical trials, and managing clinical trials, national validation studies, post-market surveillance, and hemovigilance studies. This role involves providing strategic direction and operational leadership for the clinical affairs team, ensuring compliance with regulatory requirements, and fostering relationships with key stakeholders.

Responsibilities

• Set clinical strategies for all business area projects.
• Develop objectives, plans, and protocols for clinical trials.
• Conduct, coordinate, and manage clinical trials and studies.
• Manage the Clinical Advisory Board (CAB).
• Provide strategic direction and operational leadership for the clinical affairs team.
• Ensure a culture of quality and compliance exists in the business area.
• Lead and approve development of clinical strategy to support product claims and regulatory strategy.
• Supervise clinical staff and oversee relationships with vendors for clinical activities.
• Establish and maintain global procedures for conducting clinical trials.
• Direct the professional growth of staff through guidance and training.
• Resolve complex and sensitive issues with senior colleagues.
• Ensure clinical study proposals meet regulatory and business requirements.
• Negotiate clinical research organization agreements and investigator agreements.
• Oversee preparation of clinical evaluation reports and documentation for regulatory submissions.
• Develop, monitor, and report metrics to improve trial performance.
• Lead business area Clinical Advisory Boards and the company's Clinical Advisory Board.

Requirements

• Bachelor's degree in nursing, medicine, biological sciences, or related scientific discipline required.
• Advanced degree (PhD, MD) in medicine, nursing, biological sciences, or related scientific discipline preferred.
• Minimum of 10 years clinical experience in the medical device or pharmaceutical industry conducting clinical trials required.
• Minimum of 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.

Nice-to-haves

• International clinical trial experience is a plus.

Benefits

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