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 outside of the company to resolve highly complex and sensitive issues.
• Ensures that proposals and/or protocols for clinical studies meet regulatory requirements, international standards including ICH, CFR, and ISO guidelines and requirements, business goals, and company SOPs.
• Directs activities relating to negotiating clinical research organization agreements, investigator agreements and clinical site selection.
• Responsible for resolution of customer complaints related to clinical trials; Oversees and approves the preparation of clinical evaluation reports
• Responsible for developing, monitoring, and reporting metrics designed to improve and assess trial performance, including speed and effectiveness of site start-up, training, speed and accuracy of screening, recruitment, protocol adherence, data collection and reporting.
• Leads all business area Clinical Advisory Boards and the company’s Clinical Advisory Board.  Responsible for bringing in subject matter experts as needed.
• Fosters an ongoing proactive relationship with Regulatory Affairs, R&D, Scientific, Quality, Legal, Manufacturing and Marketing colleagues to meet business goals and set priorities.
• Leads external groups participating in clinical trials, including clinical research organization, principal investigator groups, and data safety monitoring boards.
• Accountable for planning, coordinating, monitoring, and reporting on clinical studies conducted for the business.
• Oversees preparation of clinical reports/documentation for regulatory submissions and/or publications derived from clinical trials.
• Reviews and approves study reports to determine that study/trial objectives are met and that the results are valid from a clinical perspective.
• Responsible for developing, preparing, and maintaining department budget.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Four-year Bachelor of Science in nursing, medicine, biological sciences, or in related scientific or medical discipline degree required. Advanced degree (PhD, MD) in medicine, nursing, biological sciences, or in related scientific or medical discipline is preferred. Equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum of 10 years clinical experience, with increasing responsibility 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 is required.
• International clinical trial experience is a plus.

Skills

• Extensive knowledge and understanding of clinical trial reporting requirements and regulatory requirements.
• Thorough knowledge of the physiology and clinical practice of the relevant therapies.
• Knowledge of medical statistics and experimental design.
• Broad knowledge of clinical methods, both laboratory and therapy delivery related.
• Extensive knowledge of clinical study (GCP) and good working knowledge of regulatory requirements.
• In-depth technical knowledge of international medical device regulations, standards, policies, and guidance documents.
• Ability to solve practical problems and interpret and communicate complex clinical requirements in a manner that allows maximum flexibility without compromising compliance.
• Demonstrated ability to select, manage, motivate, lead, influence and develop clinical skills in Associates of varying levels of experience. 
• Capacity to define and communicate challenges and provide guidance to top management by developing and implementing positive and proactive solutions. 
• Excellent written and oral communication skills and a proven ability to communicate effectively.  Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
• Demonstrated ability to interact productively and to effectively influence peers, external colleagues, and senior management.
• Willingness to take ownership and accept responsibility for actions and decisions.
• Demonstrated ability to use strategic thinking and development of strategic proposals.
• Ability to help management teams balance clinical requirements with business requirements and identify solutions to meet both sets of needs.
• Strong interpersonal and conflict management skills, maturity and good judgment and capability of communicating with a diverse range of individuals.
• Must be detail oriented, well organized, and able to work both independently and in teams.
• Demonstrated effective leadership, managerial, and strategic planning skills.
• Demonstrated ability to interact productively and cross-functionally to effectively influence team, peers, colleagues, and senior management. 
• Ability to establish effective working relationships with all levels of the organization.
• Industry experience in representing the business during early collaboration meetings with regulatory authorities and conferring with those regulatory authorities regarding pending and proposed submissions.
• Demonstrated self-direction, initiative, and ability to work independently.
• Demonstrated positive and proactive approach to identification and definition of problems and the development and implementation of solutions. 
• Advanced presentation and communication skills, especially the ability to frame complex clinical issues in an easy-to-understand manner.
• Proficient computer and organizational skills.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Lakewood, Colorado - Open to Remote. 

TRAVEL 

U.S. and international travel will be required at 25% - 30% (periodically 50%).

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $196,600.00 to $245,700.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  30.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.