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Director, Global Scientific Affairs

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Date: Sep 14, 2022

Location: Lakewood, US

Company: Terumo BCT, Inc.

Requisition ID:  29665  

 

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 Director, Global Scientific Affairs – BCS (Blood Collection Systems), PI (PIasma Innovation) and TS (Therapeutic Systems)

 

JOB SUMMARY

This position is responsible for leading the Global Scientific Affairs Team for BCS, PI and TS for TerumoBCT.  The position will build the scientific imperatives for life-cycle management of pre and on-market products. The incumbent leads the scientific affairs team through the process of unmet need identification, data generation, analysis and data dissemination cycle aligned to business need. The Director, Global Scientific Affairs partners with global cross-functional teams (Ideation, Engineering, Sales & Marketing, Medical Affairs, Strategic Publications Regulatory & Quality) to develop innovative products and applications. This position reports to the VP of Global Scientific and Clinical Affairs |Medical Safety.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Drive the global scientific strategy for the development of Terumo Blood and Cell Technologies’ products for BCS (Blood Collection Systems) and TS (Therapeutic Systems)
  • Provide critical scientific input across the product lifecycle to influence product strategy development and design from Ideation to sunsetting of products (Phase IA – III) scientific development, pre-registration, label extension, pre- and post-market scientific launch strategies, and life cycle management
  • Provide scientific thought leadership at scientific conferences/meetings to foster and develop scientific awareness of Terumo Blood and Cell Technologies’ products in BCS and TS space
  • Serve as a subject matter expert on BCS and TS by maintaining expert knowledge and understanding of scientific and technical information via literature reviews, conference attendance and liaison with experts
  • Provide leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
  • Leverage scientific-based rigor that enables the development of compelling strategies in support of successful registration, marketing and launch of commercially viable products
  • Works with global development colleagues, including sales & marketing material development and review; organizing, presentations and leadership of advisory boards; strategy development and implementation, with a focus on meeting the needs of a diverse set of stakeholders
  • Contribute to the development of new indications for existing products
  • Provides scientific and review for regulatory submissions for company’s products

 

OTHER DUTIES AND RESPONSIBILITIES

  • Develop and implement reliable and high-value communication strategies for new and existing products
  • Cultivate a positive team environment and interact with global clinical, scientific, engineering, ideation, strategic publications, regulatory and marketing teams
  • Prioritize and resource scientific pre-market launches and post-market medical device programs
  • Successfully create a bridge between engineering innovation/NPD/Sustaining, clinical development teams and provide scientific expertise to the commercial product development teams

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Advanced degree: Graduate degree in scientific discipline - Doctor of Philosophy (Ph.D.) or MD/PhD

 

Experience

Minimum 10 years of relevant experience. 5 years of demonstrated leadership preferred. Prior experience of development of BCS and TS devices and protocols, as demonstrated by generated intellectual property, is highly preferred. Solid knowledge of blood, bone marrow and cell therapy technologies required. Knowledge of statistical analysis and related software, as demonstrated through certification in statistics or biostatistics, is strongly preferred.

 

Prior experience of academic and medical device industry is an advantage. Strong knowledge of the multiple disease state and landscape. Broad knowledge of development, clinical trial design, regulatory requirements, payer landscape and life cycle management. Prior experience of interaction with regulatory agencies, US FDA, is preferred. Project or program management is an advantage.

 

Skills

  • Product and process development knowledge in the field of BCS and TS.
  • Clinical protocol development for combination devices (medical devices and cells; IDE path)
  • Working knowledge of cGXP (GLP, GMP. GCP), scientific and clinical methodology, clinical protocol design and project management skills
  • Ability to lead cross-functional teams without formal authority
  • Demonstrates open, available, transparent, credible communicator and excellent presenter
  • Role models ethical, legal, and professional standards in the execution of their responsibilities
  • Demonstrated ability to engage with Key Opinion Leaders (KOL) at a scientific level and cultivate meaningful KOL relationships

 

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.

 

Additional Physical Requirements

Travel as needed.

 

Target Pay Range:  $211,400.00 to $264,200.00  -  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. 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.


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