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VP Global Scientific & Clinical Affairs/Medical Safety

Date: Aug 17, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23587  

 

The Vice President of Global Scientific, Clinical Affairs and Medical Safety is responsible for leading all Scientific, Clinical and Medical Safety activities for the company. This involves the successful development, implementation and execution of investigational clinical trials and establishing clinical safety for a broad line of products and services, including medical devices for the blood banking industry, hospital sector and biotech/pharma sectors. Working closely with organizational leaders, identifies global scientific and clinical development strategies which support the company’s strategic objectives relative to new product approvals and product life cycle management strategies. Delivers cross-functional leadership, drawing out globally diverse thinking and idea generation, integrating best-in-class scientific and regulatory perspectives along with front-line customer understanding that ensures patient safety and optimizes product development cycle times, market adoption and commercial success. Provides inspirational guidance, bringing out the best in associates by instilling a bias for action, commitment to excellence, and a high-performing culture focused on streamlining development pipelines. Develops and maintains relationships with key opinion leaders and thought leaders in the Blood Bank Technologies, Transfusion Medicine, and Cell Therapy industries. Ensures all business, Scientific and Clinical Affairs and Medical Safety activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.

 

ESSENTIAL DUTIES

  • Leadership of Global Scientific, Clinical Affairs and Medical Safety, ensuring a motivating environment of high value contributions in support of the company’s strategic plan.   
  • Create the global Scientific, Clinical Affairs and Medical Safety strategies to align with business goals and priorities, ensuring that the impact of global Scientific and Clinical submissions activities is included in the development of corporate strategies. 
  • Drive the global 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. 
  • Responsible for the company’s worldwide Scientific, Clinical Affairs and Medical Safety activities, both strategically and operationally.
  • Provides critical input to the development of Scientific, Clinical Affairs and Medical Safety strategy and accountable for design/conduct of investigational clinical studies for all business areas including evolution and enhancements of existing products, as well as research and development of new and emerging products and services.
  • Assures all Scientific, Clinical Affairs and Medical Safety activities are conducted according to applicable or the highest international regulatory, quality and clinical standards.
  • 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.
  • Communicates and consults/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.
  • Accountable for patient safety throughout clinical development and on-market product life cycle.
  • Develops both long-term strategic and short-term operational plans designed to support the achievement of company objectives. Ensures successful execution according to agreed upon milestones and timelines.  Anticipates, proactively pre-empts, and resolves problems and/or obstacles to ensure milestones and deadlines are met and project/program delays are minimized. 
  • Regularly monitors the external environment.  Develops and maintains a deep understanding of the scientific and clinical landscape as it relates to Terumo BCT’s long term business strategies. Remains abreast of competitive development trends, industry practices, relevant legislation and customer needs.
  • Establishes expectations and monitors delegated activities of direct reports to accomplish business objectives and achievement towards annual operating plans.  Develops leadership capabilities within their direct reports and future leaders. 

 

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Advanced degree (MS, PhD, PharmD) in life sciences, medicine, or related disciplines and/or a 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 and scientific strategies spanning the development life cycle (proof of concept to commercialization), ideation, feasibility, development, clinical trials and 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 I to class III, Premarket Approval (PMA) 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 and literature analysis.
  • Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
  • Expertise in cellular therapy combination products and/or biologics desirable.
  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential along with experience in interactions with all other health authorities.
  • Demonstrated success leading the development and implementation of complex organizational change efforts designed to continuously improve performance, adoption and execution of best-in-class processes, and application of scientific expertise to achieve or exceed organizational performance objectives.
  • Demonstrated success in leveraging program and project management disciplines, methodologies and practices to accomplish goals, objectives, timelines and milestones.
  • 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 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.

 

Additional Physical Requirements

Travel is required, given the global scope of the job, and would vary in intensity depending on the evolving business needs. Anticipated travel to be around 20-25%.

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

Job Segment: Medical, Scientific, Clinic, Biotech, Telecom, Healthcare, Engineering, Science, Technology