Axiom is seeking a Medical Technical Advisor to support a high-visibility project for a program leading the Department's enterprise for developing, acquiring, and fielding next-generation medical capabilities that enhance Warfighter lethality, survivability, and readiness. This position provides engineering and scientific expertise for medical products, including medical devices, diagnostics, drugs, biologics, and other medical countermeasures designed to protect and treat Warfighters in combat and operational environments. Responsibilities
- Provide expertise in medical devices, diagnostics, drugs and biologics, and/or other medical countermeasures relevant to Warfighter protection and acute care.
- Provide clinical management expertise for DoD-sponsored and non-DoD-sponsored clinical research activities, including planning, designing, coordination, management, and conduct of clinical trials.
- Orchestrate regulatory strategy and compliance activities for products, ensuring alignment with FDA requirements and DoD acquisition milestones.
- Assist in writing and preparation of clinical protocols, Investigator's Brochures, clinical study reports, and other clinical trial documents.
- Provide expert written reviews, briefings, and recommendations for developmental medical projects at various stages of the acquisition lifecycle.
- Support scientific preparation of results for publication in peer-reviewed journals and presentation at scientific conferences.
- Serve as a subject matter expert on IPTs, providing technical and clinical guidance to Product Managers and program staff.
- Review program documentation for technical and scientific accuracy, including Test and Evaluation Master Plans, acquisition milestone documentation, and regulatory submissions.
- Maintain current knowledge of relevant technology developments, clinical evidence, and industry trends in Warfighter protection and acute care domains.
- Provide technical risk assessments and recommendations for product development strategies, test plans, and regulatory pathways.
- Support coordination with external research organizations, academia, and industry partners on WPAC product development initiatives. Requirements
- Medical degree (M.D./D.O.), doctorate (Ph.D.), or other advanced degree or certification in a medical, scientific, or technical field relevant to Warfighter protection, acute care, trauma medicine, or related biomedical disciplines.
- Capability of applying knowledge of DoD's acquisition process (DoDI 5000 series) in conjunction with clinical and scientific expertise.
- Strong understanding of FDA regulatory pathways for drugs, biologics, and medical devices, including INDs, NDAs, PMAs, 510(k)s.
- Demonstrated ability to synthesize complex scientific and technical information into actionable recommendations for senior leadership.
- Strong written and oral communication skills, including experience preparing scientific publications, briefings, and technical reports.
- Ability to work effectively in multidisciplinary teams within a matrixed DoD environment. Additional Preferred Qualifications
- Experience supporting DoD medical product development programs, particularly in trauma medicine, combat casualty care, protective equipment, or acute care countermeasures.
- Clinical research experience, including protocol development, clinical trial oversight, and regulatory submissions.
- Familiarity with DHA, the Military Health System, or similar DoD health agencies.
- Experience with FDA interactions, including pre-submission meetings, regulatory submissions, and advisory committee proceedings.
- Publication record in peer-reviewed scientific or medical journals.
- Knowledge of the DoD acquisition lifecycle and how clinical/scientific evidence supports milestone decisions.
Pay:
$150,000.00 - $170,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance
Work Location:
Hybrid remote in Fort Detrick, MD 21702