Medical Advisor Support (Warfighter Readiness Performance and Brain Health)

The Job Duties and Responsibilities include but are not limited to the following:

• 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.

Required Qualifications:

• Advanced Degree (MD, DO, PhD, or equivalent) in a medical, clinical, or scientific field.
• At least 10 years of full-time work experience in medical product development and clinical trial research.
• In-depth knowledge of the development processes for drugs, biologics, and medical devices.

Preferred Qualifications:

• Expertise in pharmaceutical development within the disease areas of psychiatry or neurology (specifically PTSD and TBI).
• Extensive experience interacting with the FDA and managing clinical trial protocols.