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Beckman Coulter has partnered with the Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR), within the United States Department of Health and Human Services (HHS) to develop a machine learning algorithm that predicts sepsis, including SARS-CoV-2 viral-induced sepsis resulting from the COVID-19 pandemic. The Beckman Coulter sepsis solution is the first of a portfolio of digital diagnostics solutions to drive clinical insights from medical records and Danaher operating company (including Beckman Coulter) laboratory instrument data.
Reporting to the Director of Clinical Affairs, the Senior Staff Clinical Scientist will oversee and manage all sepsis clinical studies, following GCP and FDA requirements, that fall under the umbrella of the Danaher Diagnostics Sepsis Initiative and support two BARDA funded programs: development of ML algorithm for sepsis prediction and development of method for identification of Multi-System Inflammatory Syndrome in Children, a complication of SARS-CoV-2 infections. While the reporting line is embedded within the Beckman Coulter operating company, the position is responsible for overseeing sepsis clinical studies that may also involve products from the Danaher diagnostic companies of Radiometer and Cepheid in addition to Beckman Coulter. By positioning the different Danaher company’s sepsis product lines together through a robust clinical evidence strategy, there is an exciting opportunity to make a greater impact in improving clinical outcomes for patients with sepsis. Further, the position will work closely with the Danaher Diagnostics digital team to incorporate machine learning predictive analytic algorithms into real-world evidence study designs.
This role has the following opportunities:
Sets the clinical evidence strategy fordesign of studies of new innovative sepsis products, primarily in the digital diagnostics predictive analytics space. Works under the general guidance of the Director of Clinical Affairs to support preparing all sepsis-related clinical deliverables. Designs protocols (that adhere to Good Clinical Practices & FDA & IVDR guidelines) & case report forms based on clinical strategy.
Collaborates with potential investigators/clinical partners to further feasibility of new sepsis products
Serve as the sepsis clinical evidence workstream lead for the cross-functional, cross-operating company Danaher Diagnostics sepsis initiative team, providing monthly report-outs on progress related to implementation and execution of Danaher’s sepsis regulatory & clinical evidence strategy to Director of the Danaher Diagnostics sepsis initiative and internal sepsis steering committee.
Serves as liaison to sepsis medical advisory group. Engaging in scientific exchanges with the advisory team driving key inputs and decisions and bringing back their recommendations as well as providing updates to the advisors on project progress.
Interfaces and works closely with Biostatistics group to guide post-study data analysis including support in drafting technical disclosure agreements and provisional patent filings in close collaboration with IP/legal team
Partners with Regulatory Affairs team member to ensure alignment of clinical & regulatory strategies as well as participates in negotiations with FDA. Prepares clinical strategy for submissions that include innovative approaches utilizing real-world evidence and digital diagnostic algorithms.
Collaborate with study team members within clinicals and data management groups to execute study activities, improve processes, and generate novel solutions where required
Preparation of clinical reports and submission of manuscripts to peer-reviewed journals
The essential Requirements of this role include:
Bachelor’s degree 14+ years relevant experience or Master’s degree with 12+ years of experience or Doctoral degree with 9+ years of experience; degree in Immunology, Cell Biology, Biochemistry or related field
Working knowledge of real-world clinical data to generate real-world evidence supporting regulatory submissions
Comfortable learning and working day-to-day with new technologies and software solutions, comfortable working with large datasets
Additionally, experience in the following is helpful:
Clinical studies in IVD regulated diagnostics/medical device industry or digital diagnostics
Knowledge of sepsis therapeutic area
Knowledge of real-world clinical data management roles and activities
Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates’ lives. Whether it’s a health care program or paid time off, our programs enhance life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
Work hard and with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of Danaher's 67,000 associates across the globe, the possibilities for growth and development are unparalleled.
We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that’s why we’re taking concrete steps to ensure that we’re fostering an inclusive and engaging workplace. To learn more, read about our associates on our Careers Blog or contact one of our recruiters.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
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Internal Number: R1151331
About Beckman Coulter Diagnostics
As part of the Danaher family of companies, our work at Beckman Coulter is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.