VP Global Scientific & Clinical Affairs/Medical Safety

Requisition ID:  30891  

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.

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.

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. Consider joining our team and unlock your potential. 

JOB TITLE: Vice President – Global Scientific and Clinical Affairs/Medical Safety

JOB SUMMARY

The Vice President of Global Scientific, Clinical Affairs and Medical Safety is responsible for leading all related activities for TerumoBCT (Blood and Cell Technologies).  This role reports into the Senior Vice President for R&D and leads a team of approximately 70 associates responsible for the successful development, implementation and execution of investigational scientific and clinical trials.  The incumbent also has oversight for establishing clinical, patient safety for a broad line of products and services including medical devices for the blood banking industry, hospital sector, and biotech/pharma sectors.

This role delivers value by successfully partnering with Commercial leaders and other key stakeholders to deliver scientific and clinical data that ensures patient safety, enables market adoption and commercial success. 

ESSENTIAL DUTIES

• Partners with leaders across key functions such as Commercial, Pre-product development, New Product Development, Regulatory and Medical Affairs to identify global scientific and clinical development strategies which support the company’s objectives relative to new product approvals and product life cycle management
• Drives the Scientific and Clinical Affairs strategy for the development of U.S. class II and class III medical devices, PMA products, associated pharmaceuticals to be used with our medical device products, CE Mark class IIa, IIb, and III devices, and many products manufactured and or registered in other countries 
• Cultivates globally diverse thinking and idea generation, integrating best-in-class scientific and regulatory perspectives combined with front-line customer awareness
• Brings out the best in associates by instilling a bias for action, commitment to excellence, and a high-performing culture focused on streamlining development pipelines
• Ensures all business, Scientific/Clinical Affairs and Medical Safety activities are in accordance with applicable laws, rules and regulations of the intended markets and meet high quality standards and customer and patient expectations
• Cultivates and maintains relationships with key opinion and thought leaders in the Blood Bank Technologies, Transfusion Medicine, and Cell Therapy industries as it applies to scientific and clinical development/trials
• Establishes a vision aligned to company focus and provides oversight to ensure plans are appropriately executed to accomplish business objectives and annual operating plans are achieved
• Develops leadership capabilities and ensures a strong succession plans for key leadership positions
• Develops and deploys the systems, processes, and capabilities which enable the Company to proactively monitor patient safety and product quality trends, including clinical safety and post market surveillance activities

OTHER DUTIES AND RESPONSIBILITIES

• Collaborates with leaders, product development teams and other functions on topics related to the successful application of human factors or anthropological, ethnographic, or Gemba approaches to ensure safety
• Effectively leverages experience to anticipate and resolve problems to ensure milestones and deadlines are met and project/program delays are minimized 
• Develops and maintains a deep understanding of the scientific and clinical landscape as it relates to Terumo BCT’s long term business strategies and remains abreast of competitive development trends, industry practices, relevant legislation and customer needs

LEADERSHIP COMPETENCIES AND SKILLS

• Makes it Happen Together: Navigates uncertainty and leads through change by focusing on desired results, creating vision, and executing collaboratively
• Brings Out the Best in Others: Creates an inclusive and trusting environment where associates and teams are engaged, developed, and can contribute their best
• Champions a Growth Mindset: Observes and listens with curiosity to customer and market needs, experiments with new ways of working, and learns from successes and mistakes
• Experienced with program and project management methods and tools
• Culture/Motivational Fit – can thrive and work in a VUCA environment (volatility, uncertainty, complexity, ambiguity), and willing to travel with flexible work hours driven by global time zones

MINIMUM QUALIFICATION REQUIREMENTS

Education

Advanced degree (MD, MD/PhD, PhD, PharmD) in life sciences, medicine, or related disciplines and/or combination of related education and experience sufficient to successfully perform the role required.  MD or MD/PhD desired.  

Experience & Skills

• Minimum 10 years leadership experience in the realm of translational research, clinical development or other related fields.  Minimum 5 years global people management experience in a highly matrixed, global environment at a senior level
• Proven success in bringing new products to market, broad and deep expertise in the development and execution of robust, clinical, scientific strategies spanning the development life cycle (proof of concept to commercialization), ideation, feasibility, development, clinical trials, & clinical pull-through
• Successful track record in leading complex, global organizations responsible for the development and implementation of global clinical, scientific and medical safety programs in medical devices ranging from class 1 to class 3, Premarket Approval (PMAs) products, and associated pharmaceuticals to be used with our medical devices 
• Expertise in the area of product safety compliance, post market surveillance, reporting, health hazard analysis, literature analysis
• Expertise in cellular therapy combination products, transfusion, apheresis and plasma desirable
• Knowledge of relevant US FDA regulations and guidelines as well as those of the EU (EUMDR/CER/PMCF)  and other Global health authorities; experience in interactions with FDA personnel is essential along with experience in interactions with all other health authorities

• Demonstrated ability to manage highly complex budget, investment, and human capital portfolios, including both in-sourced and out-sourced resourcing models

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.

Travel 15-25%

Target Pay Range:  $356,000.00 to $445,000.00  -  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:  45.0%

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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.