Clinical TrialMedical Development Technical Advisor Support (Warfighter Protection and Acute Care)

Odyssey is looking for a Clinical Trial/Medical Development Technical Advisor (Warfighter Protection and Acute Care) supporting the Defense Health Agency (DHA) at Ft. Detrick MD. The Technical Advisor Support provides advanced clinical and scientific management expertise for DoD-sponsored clinical research activities within the WPAC division. This expert will assist in the planning coordination and conduct of clinical trials for medical devices diagnostics drugs and biologics to treat acute care requirements.

***Contingent upon contract award***

Duties include but are not limited to:

• Provide clinical management expertise for the planning designing coordination management and conduct of clinical trial research.
• Assist in the writing and preparation of clinical protocols and other clinical trial documents.
• Interpret synthesize and incorporate new information from the FDA and other policy bodies into organizational strategy.
• Assist in the development of comprehensive Integrated Master Plans for FDA and non-FDA regulatory and clinical activities.
• Advise product managers on the product development lifecycle identifying regulatory requirements at each stage for drugs biologics and devices.
• Provide professional medical review of Investigational Device Exemptions IND protocols and packages.
• Provide subject matter expertise in pharmaceutical quality/chemistry manufacturing and controls (CMC).
• Support scientific preparation of results for eventual publication in peer-reviewed journals.

***Contingent upon contract award***

Minimum Required Qualifications:

Citizenship: Must be a US citizen.

Clearance: Ability to Obtain NACI.

Education: Advanced Degree in a medical clinical or scientific field.

Years of Experience: At least 10 years of full-time work experience in medical product development and clinical trial research.

Other Experience:

• In-depth knowledge of the development processes for drugs biologics and medical devices.

Preferred Qualifications:

Years of experience: Extensive experience interacting with the FDA and managing clinical trial protocols. And/or prior experience supporting military medical research and development. Experience with DHA/USAMMDA preferred

Additional Information

Location: Defense Health Agency (DHA) 1430 Veterans Drive Fort Detrick MD 21702.

Travel: 10%.

Remote Onsite or Hybrid: Onsite.

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***Contingent upon contract award***

Odyssey is a world-class technical engineering and integration company serving the warfighting ecosystem with airborne integration ISR C2 and warfighter readiness capabilities. Odyssey meets the militarys operational needs by integrating layered defense systems from equipment technology and services to data information and business operations. We streamline defense acquisition and sustainment engineering the technical battlefield with domain-specific proficiency to ensure lethality. Odyssey is dedicated to excellent contract execution peak organizational performance and fostering a workplace built on employee care.

Odyssey is proud to live out our core values of commitment ambition and respect in our work and communities through OdysseyCares a philanthropic group focused on giving back through direct donations an employer match program and volunteering events.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates relevant work experience specific skills and competencies geographic location education and certifications.

This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received.

Hired applicants may be eligible for benefits including but not limited to medical dental vision life insurance Tricare supplement short-term disability long-term disability 401(k) match flexible spending accounts health savings accounts employee assistance program learning and development benefit paid time off and holidays.

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