DoD Medical & Clinical Research Advisor

Arcetyp LLC; United States; Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Arcetyp LLC, Fort Detrick, MD, is seeking a DoD Medical & Clinical Research Advisor to provide medical/scientific SME support for medical devices, diagnostics, drugs, biologics, and related solutions. This onsite role requires deep clinical research expertise and the ability to deliver senior-level recommendations on regulatory strategy and trial design.

The ideal candidate holds a medical degree or equivalent and can apply DoD acquisition knowledge to clinical programs, with up to 20% travel.

Qualifikationen

• Medical degree, doctorate, or related advanced degree.
• Experience applying DoD acquisition knowledge to clinical programs.
• Familiarity with FDA/IND/IDE regulatory submissions.
• Ability to travel up to 20% for duty locations.

Aufgaben

• Provide medical/scientific SME support for devices, diagnostics, and therapies.
• Provide clinical management expertise for clinical research and trials.
• Review protocols, IND/IDE packages, CMC docs, safety data, and submissions.
• Support coordination with FDA, EPA, DoD, DHA and JTS.

Kenntnisse

Clinical research

Medical product development

Regulatory strategy

Clinical trial design/oversight

DoD acquisition knowledge

Ausbildung

Medical degree or equivalent

Jobbeschreibung

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services.

We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B.

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. 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.

Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.