Director, Clinical Affairs

Requisition ID: 32801  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The Director of Clinical Affairs is responsible for setting clinical strategies for all business area projects. Develops objectives, plans, and protocols for clinical trials to achieve end results that support the organization’s business strategies and goals. Overall responsibility to conduct, coordinate and manage clinical trials, national validation studies, post market surveillance, and hemovigilance studies. Manages the Clinical Advisory Board (CAB) for the organization. 

ESSENTIAL DUTIES

• Provides strategic direction and operational leadership for clinical affairs team and business.
• Develops and communicates effective clinical strategies to meet established business goals. 
• Provides intentional influence to ensure that a robust, day-to-day ‘culture of quality and compliance’ exists in the business area or region.
• Responsible for leading and approving development of clinical strategy to support product claims and regulatory strategy. Responsible for successful execution and implementation of clinical strategy, including supervising clinical staff, building relationships with principal investigators, and overseeing relationships with vendors responsible for execution of all clinical activities.
• Participates on Management Teams for business areas.
• Responsible for overseeing the establishment and maintenance of global procedures/processes for conducting clinical trials and studies Terumo BCT in all geographic locations and in accordance with standardized set of operating procedures in all geographies.
• Directs the professional growth of staff by providing individualized guidance, training, and supervision.
• Works closely with other senior level colleagues within and …