DoD Medical & Clinical Research SME

Arcetyp LLC; Gaithersburg (MD); Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company matching

Paid time off

Job summary

Arcetyp LLC seeks a DoD Medical & Clinical Research Advisor to support medical products and regulatory submissions. This onsite role at Fort Detrick, MD requires senior clinical/scientific acumen and DoD acquisition insight.

Responsibilities include SME support for medical devices, trials, and regulatory packages, with collaboration across DoD and federal agencies. Strong clinical leadership and regulatory strategy are essential.

Qualifications

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

Responsibilities

• 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.

Skills

Clinical research

Regulatory strategy

FDA-regulated products

Clinical trial design

Data review & interpretation

Education

Medical degree or equivalent

Job description

Arcetyp LLC seeks a DoD Medical & Clinical Research Advisor to support medical products and regulatory submissions. This onsite role at Fort Detrick, MD requires senior clinical/scientific acumen and DoD acquisition insight.

Responsibilities include SME support for medical devices, trials, and regulatory packages, with collaboration across DoD and federal agencies. Strong clinical leadership and regulatory strategy are essential.