Small Molecule Subject Matter Expert
The contractor will work in developing and transitioning small molecules into animal models and human clinical studies. Contractor will serve as a Study Director on small molecule drug development for IND, Phase I, II and III FDA submission. Work on pK and Toxicity studies. Contractor will make contributions to drug development projects that have been selected to move forward into animal studies and ultimately FDA clinical trials. USAMRIID has compounds identified as interest, and needs assist in the preparation of manuscripts and evaluation of animal model pK data, developing an animal testing model for both the alpha and the filoviruses. Project continuation depends on the achievement of project-specific milestones. Specific responsibilities include:
- Provides guidance on the design and interpretation of commonly used in vivo assays such as pK and other delivered by research service contractors. Shall input on the project endpoints and milestones.
- Shall evaluate and provide feedback on project strategies from the perspective of FDA requirements and regulations. Consultant shall provide feedback and guidance on USAMRIID projects and guidance on USAMRIID projects through conference call and by email.
- Shall assist with the preparation of manuscripts that result from the research completed as part of the FDA Repurposing Program. Analytical reports for each compound and animals will be completed within 2 weeks of receipt.
- Prepares monthly Small Molecule Technical Report.
Masters Degree in a scientific discipline. PhD is highly preferred.
10-15 years of related experience in scientific research, analysis and/or engineering.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.