Arcetyp LLC is looking for a DoD Medical & Clinical Research Advisor. This position is onsite and located in Fort Detrick, MD.
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.
Min. Citizenship Status Required:
U.S Citizenship.
LOCATION:
Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
