Medical Device)

Lexical Intelligence, LLC•Rockville, MD

4d•Onsite

About The Position

Lexical Intelligence provides software and services related to processing large-scale biomedical information sources. Our Natural Language Processing (NLP) and analytics software is used by policy and decision makers to evaluate and prioritize current and emerging areas of research. We are looking for a Senior Scientist / Engineer (Oncology / Medical Device) to work within the Advanced Research Projects Agency for Health (ARPA-H), Health Science Futures (HSF) Mission Office. The Senior Scientist / Engineer will have experience in medical device development (hardware and software), oncology and cancer biology, and biomedical research and engineering. The Senior Scientist / Engineer will have a firm understanding of R&D program management, diagnostic device development, and regulatory affairs in diagnostics. The Senior Scientist / Engineer shall be able to work well within a team of program managers, scientists, engineers, and government stakeholders. The selected applicant will be subject to a pre-employment background and reference check.

Requirements

8+ years of relevant industry experience in biotechnology, biopharmaceutical, or diagnostics companies
PhD or other advanced degree(s) in Biomedical Engineering, Oncology, Cancer Biology, Biochemistry, Cell Biology, Mechanical Engineering, Chemical Engineering, or related fields
Demonstrated expertise in medical device development, including both hardware and software components
Strong oral and written communication skills, with the ability to convey complex technical information to both technical and non-technical audiences
Proficiency in Microsoft PowerPoint and Excel, including the ability to create presentations and spreadsheets in real time during high-pressure meetings using keyboard shortcuts
Must be able to obtain a federal government Public Trust clearance
Must be authorized to work in the United States
Experience in medical device development (hardware and software)
Experience in oncology and cancer biology
Experience in biomedical research and engineering
Firm understanding of R&D program management
Firm understanding of diagnostic device development
Firm understanding of regulatory affairs in diagnostics
Ability to work well within a team of program managers, scientists, engineers, and government stakeholders

Nice To Haves

Prior experience at diagnostics startups or mid-cap companies with exposure to regulatory affairs in diagnostics
Experience supporting executives managing large-budget R&D programs
Background in both basic and applied research environments
Demonstrated ability to conduct thorough technical evaluations of the R&D landscape, including identifying research gaps and critical unmet needs
Experience monitoring and tracking program performance metrics
Strong logical and critical thinking skills with the ability to critically review scientific and technical data
Professional curiosity, continuous drive for learning, and the ability to independently manage and prioritize assigned tasks

Responsibilities

Assist, support, and provide advice to the ARPA-H Program Manager to further the development and progress of new and existing R&D programs
Conduct thorough technical and scientific evaluations of the current R&D landscape to identify gaps in research portfolios and address critical needs aligned with the ARPA-H mission to accelerate better health outcomes
Monitor and track performer progress toward established program metrics and milestones
Read and synthesize complex scientific information and develop team and executive-level briefings tailored for both technical and non-technical audiences
Critically review scientific and technical data using strong logical and analytical thinking skills
Integrate into an existing team to support current ARPA-H efforts while also operating independently in support of technical R&D initiatives
Perform programmatic administrative tasks, including collecting, sorting, analyzing, and writing internal reports and briefings on relevant health-related topics
Support the development, funding, and management of new and existing R&D programs in oncology and medical device development
Participate in CONUS travel (approximately 10–20%) as needed to fully support the Program Manager and program activities
Ensuring compliance with organizational security and privacy policies, protecting sensitive data and systems, reporting security incidents, and participating in required cybersecurity training.
Implementing best practices related to access control, data handling, and risk mitigation within the scope of assigned duties.