DoD Medical & Clinical Research Advisor - Telework

Essential Job Functions:

• Provide medical/scientific SME support for medical devices, diagnostics, drugs, biologics, blood products, medical countermeasures, PTSD/TBI, or related medical solutions.
• Provide clinical management expertise for clinical research and clinical trials.
• Review protocols, IND/IDE packages, CMC documentation, safety data, and regulatory submissions.
• Support FDA, EPA, DoD, DHA and JTS coordination.
• Participate as a substantive IPT SME.

Necessary Skills and Knowledge:

• Clinical research and medical product development.
• FDA-regulated products.
• Clinical trial design/oversight.
• Regulatory strategy.
• Ability to review complex medical/scientific data and provide senior-level recommendations.

Minimum Qualifications:

• Medical degree, doctorate, other advanced degree, OR certification in a medical, scientific, or technical field related to the applicable medical product development area.
• Ability to apply DoD acquisition knowledge with relevant clinical/scientific expertise.
• Travel: Up to 20%

Preferred Qualifications:

• Current WRPBH/DHA medical advisor incumbent.
• PTSD/TBI, neuroscience, neurology, psychiatry, or Warfighter performance experience.
• Clinical trial experience.
• FDA/IND/IDE experience.
• CMC/GMP knowledge.
• Military medicine experience.