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Director of Clinical Applications

Company: SPECTRUM INTERMEDIATE LLC
Location: Draper
Posted on: May 14, 2022

Job Description:

For over 14 years, Spectrum Solutions has been a single-source provider of high-quality consumer product innovation providing customers measurable process optimization, unmatched scalability, and overall cost savings. With full-service on-site manufacturing, custom packaging, kitting, fulfillment, and global logistics, our technology, products, and services provide the industry with full product development-to-delivery solutions. Our commitment and mission are to: "Build the best products. Champion the simplest solutions. Deliver as promised". At Spectrum we believe that opportunities and creativity pave the way to innovation. Here your passion, resourcefulness, and perseverance will do more than just join something, they will add something. Spectrum Solutions is seeking a Director of Clinical Applications to support testing and monitoring of disease from saliva, as part of the company's R&D pipeline. Spectrum has developed several new devices which will provide patients and providers a non-invasive method to detect clinically relevant genetic, transcriptomic, and proteomic markers. The Director of Clinical Applications will be responsible for supporting the development of study plans meant to highlight the capabilities of Spectrum's device across existing and emerging laboratory technologies. Incumbent will work closely with Spectrum's partner laboratories to execute study plans, including identifying and managing key project resources and providing regular updates to Spectrum's R&D leadership. Individual will be responsible to collating all data produced into reports that can be further used for regulatory affairs and translated into scientific and marketing opportunities. The Director of Clinical Applications will report to the Chief Medical Officer. Job Duties and Responsibilities:

  • Lead the development and optimization of Spectrum's device across an array of medical applications used to screen, diagnose, and monitor disease (oncology, immunology, infectious disease, neurology, endocrinology, etc.) in collaboration with partner laboratories.
  • Formulate clear study plans, including protocols, budgets, and timelines to support all technical aspects
  • Actively seek and submit grant applications to support current and upcoming projects.
  • Deliver clear and concise reporting on the progress of each study. Compile data into final report that may be further utilized for abstract, poster, and journal submissions.
  • Work with CMO and CSO to evaluate novel application opportunities including literature reviews, discovery efforts and external laboratory assessments.
  • Represent Spectrum's endeavors at scientific congresses, including presentation planning and delivery in coordination with marketing team.
  • Support scientific input for regulatory requirements associated with Spectrum's product development pipeline and technical submissions with collaborators. Education/Experience:
    • Degree: B.S. / M.S. required; PhD preferred
    • 5+ years of experience in developing diagnostic technical applications
    • Breadth of knowledge across biological diseases and associated biomarkers
    • Regulatory familiarity with 510K and Laboratory Developed Tests
    • Experience with scientific publications and congresses
    • Ability to move effectively and expeditiously in alignment with project timelines
    • Background in multi-site clinical trial/study management Computer Skills:
      • Proficient with Microsoft Office Suite or related software. Spectrum Solutions is an equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any other basis covered under applicable law. PI173366113

Keywords: SPECTRUM INTERMEDIATE LLC, Draper , Director of Clinical Applications, Healthcare , Draper, Utah

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