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Senior Clinical Research Scientist

Date: Apr 18, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23150  

 

Terumo BCT is looking for a Senior Clinical Research Lead to join us in our mission to Contribute to Society through Healthcare. As a member of our new clinical development team, the Senior Clinical Research Lead has a deep understanding of clinical study design, research, and clinical development strategy. The clinical development team a clinical design capability with cross-functional expertise to deliver consistent, high quality clinical designs.

As a Senior Clinical Research Lead on our Clinical Development team, you will play a key role in the creation and implementation of global clinical trials and clinical development strategies by providing leadership and clinical science expertise. While the primary responsibilities include designing clinical plans and producing necessary deliverables (study protocols, analysis plans, study reports, and publications), you may work on trials across early and/or late phases of development and commercialization of the product. There will also be opportunities for you to provide consultative clinical science leadership to internal and external groups, interact with key opinion leaders, and join in activities such as outreach aimed at the clinical customer community.

Are you ready to do work that matters? Read on to find out more about the Lead Clinical Science Lead position and how to join us at Terumo BCT.

Clinical Design & Planning

  • Lead the development and execution of clinical development plans for one or more medical device programs, ensuring that business needs are aligned with clinical strategy and interface with senior leadership regarding business-development alignment
  • Provide clinical leadership and insight to design control and strategic commercial activities
  • Collaborate with regulatory affairs, scientific affairs, medical affairs, project management and the design team in the development and design of the protocols.
  • Draft, review, and issue deliverables of the clinical development plan, including clinical study protocols, protocol amendments, informed consents, clinical study reports, abstracts, and manuscripts for peer-review
  • Partner with Head of Clinical to approve protocols.
  • Closely collaborate with Medical affairs, commercial, and market access teams to maintain a good understanding of their patients, medical and payer communities, and business strategy.
  • Facilitate communication about clinical development planning and strategy for internal cross-functional teams, senior leadership, and externally for advisory boards
  • Represent the clinical affairs department to multi-functional core teams, regulatory correspondence, KOLs, and vendors to ensure that clinical development program requirements are met

Clinical Research, Execution and Support

  • Collaborate with clinical research staff with the design and conduct of clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions).
  • Provide oversight for clinical study conduct
  • Facilitate regulatory submissions and communications by coordinating with regulatory affairs during the submission process and represent clinical development topics to regulatory agencies
  • Understand, interpret, and summarize the results of statistical analysis, and guide follow-up analysis

Scientific Data Dissemination/Exchange

  • Provide knowledge of and compliance with local laws and regulations and global policies and procedures with respect to data dissemination and interactions with external health care professionals.
  • Establish and maintain appropriate collaborations and relationships with external authorities, professional societies, and the general medical community.
  • Participate in developing scientific data and preparation of final reports and publications.

Scientific Expertise and Shared Learning

  • Evaluate scientific literature, analyzing scientific data, and staying abreast of current clinical and research practices
  • Be aware of current trends and projections for clinical research, practice, and access in the therapeutic area(s).
  • Focus on organizational learning to identify standard methodologies, delivering these as systemized standard approaches the goal to make program and protocol design faster and less expensive.
  • Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, Clinical Study Reports (CSR), and use of clinical data/evidence for market access and reimbursement.

 

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: Research Scientist, Scientific, Clinic, Medical, Science, Engineering, Healthcare, Research