Clinical Trial/Medical Development Technical Advisor Support (Warfighter Protection and Acute Care)

Position Summary

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***

Responsibilities

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***

Qualifications

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.

#LI-JC1

***Contingent upon contract award***

Company Overview

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 military’s 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

Please Note:

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.Odyssey Benefits

Responsibilities

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***