Senior Clinical Trials Advisor for DoD Programs

Odyssey Systems Consulting Group, Ltd.; Frederick (MD); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

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

Holidays

Job summary

Odyssey Systems Consulting Group, Ltd. is seeking a Technical Advisor Support for the Defense Health Agency (DHA) at Ft. Detrick, MD.

The role provides advanced clinical and scientific management expertise for DoD-sponsored clinical research within WPAC, coordinating trials for medical devices, diagnostics, drugs, and biologics to meet acute care needs. Responsibilities include planning and conducting trials, developing regulatory strategies, and advising product managers on lifecycle

Qualifications

• Must be a US citizen.
• Ability to obtain NACI clearance.
• Advanced degree in medical, clinical, or scientific field.
• At least 10 years of full-time experience in medical product development and clinical trial research.
• In-depth knowledge of development processes for drugs, biologics, and medical devices.
• Experience interacting with the FDA and managing clinical trial protocols.
• Experience supporting military medical research and DHA/USAMMDA preferred.

Responsibilities

• Provide clinical management expertise for planning, designing, coordination, management, and conduct of clinical trial research.
• Assist in 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 development of Integrated Master Plans for FDA and non-FDA regulatory and clinical activities.
• Advise product managers on regulatory requirements at each stage for drugs, biologics, and devices.
• Provide professional medical review of Investigational Device Exemptions, IND protocols and packages.
• Provide SME in pharmaceutical quality/chemistry, manufacturing and controls (CMC).
• Support scientific preparation of results for eventual publication in peer-reviewed journals.

Skills

Clinical trial management

Regulatory strategy

FDA interactions

Medical product development

Education

Advanced degree in medical, clinical, or scientific field

Job description

Odyssey Systems Consulting Group, Ltd. is seeking a Technical Advisor Support for the Defense Health Agency (DHA) at Ft. Detrick, MD.

The role provides advanced clinical and scientific management expertise for DoD-sponsored clinical research within WPAC, coordinating trials for medical devices, diagnostics, drugs, and biologics to meet acute care needs. Responsibilities include planning and conducting trials, developing regulatory strategies, and advising product managers on lifecycle