Biomedical R&D Advisor

Health & Life Science
00055676 Requisition #
Thanks for your interest in the Biomedical R&D Advisor position. Unfortunately this position has been closed but you can search our 176 open jobs by clicking here.

Basic Qualifications:
BS and 5 years related experience
Applicants selected for this position will be subject to a government security investigation and must meet eligibility requirements for access to classified information or applicants who are eligible for security clearances

Required Qualifications:
Education minimum: Masters degree in a biomedical field plus five (5) years experience.
Education preferred: Doctoral degree in a biomedical field relevant to medical product development (e.g. vaccinology; immunology; virology; microbiology; or related field).
Experience in advanced development of biomedical products (e.g. vaccines, small molecules, antibodies) with either the government or private industry sectors.

Preferred Qualifications:
Experience in advanced development of biomedical products (e.g. vaccines, small molecules, antibodies) with either the government or private industry sectors. This may include experience supporting navigation of biomedical products through one or more of the following ways:

o Regulatory review. This may include knowledge of: key processes for Investigational New Drug (IND) applications, Biologics License Applications (BLA), New Drug Application (NDA), or Emergency Use Authorization (EAU); experience supporting or working with FDA Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER); or review and benefit-risk assessments of medical products.

o Clinical development. This may include experience: designing or reviewing human clinical trial protocols/reports including informed consent and documents necessary for the conduct of clinical trials; familiarity with Good Clinical Practice (GCP) standards; and with statistical analysis for clinical trial results including preparation of datasets, network meta-analysis to assess randomized interventions, and supplemental analysis using clinical trial patient-level data to answer additional research questions.

o Biomedical manufacturing. This may include knowledge of: technical and regulatory elements critical to manufacture and scale-up of advanced development or approved biomedical products (e.g. Good Manufacturing Practice (GMP); Chemistry, Manufacturing, and Controls (CMC) standards); or MCM supply chain management/distribution.

Advanced development of biomedical products for emerging infectious diseases or chemical, biological, radiological, and nuclear (CBRN) threats preferred, although other therapeutic areas will be considered.
Knowledge of the research and development, preparedness, and health security missions of DoD; HHS ASPR and BARDA; CDC; NIH; or other US government departments/agencies.
Strong written and verbal communication skills with the ability to relay technical concepts to both technical subject matter experts as well as non-technical audiences.
Eligible for USG clearance.

MITRE’s workplace reflects our values. We offer competitive benefits, exceptional professional development opportunities, and a culture of innovation that embraces diversity, inclusion, flexibility, collaboration, and career growth. If this sounds like the choice you want to make, then choose MITRE—and make a difference with us. For more information please visit U.S Citizenship is required for most positions.

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