Goldbelt Frontier fosters a collaborative environment where employees are encouraged to utilize and employ their operational and leadership skills. Many senior project managers and business analysts are subject matter experts in their respective fields. Frontier understands how to support multiple stakeholders to aid in developing and implementing national policies, strategies, and doctrine.

Summary:

The Force Health Protection (FHP) Senior Product Manager will support the U.S. Army Medical Materiel Development Activity’s (USAMMDA) Force Health Protection (FHP) Division in its mission to make available to DoD personnel Investigational New Drugs (INDs) under approved treatment protocols.

Essential Job Functions:

• Provide scientific review and technical support to the FHP Division products in support of the Director, Deputy Director, and Product Managers in the FHP Division.


• Respond to technical and scientific related questions related to products in the FHP portfolio in the areas of infectious diseases, bio-threats or molecular diagnostics


• Review the regulatory requirements for inventorying, archiving, storing, and transporting IND vaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices


• Support the planning, development, and review of Expanded Access IND protocols and their rollouts


• Support FHP involvement in any Emergency Use Authorization (EUA) as needed


• Develop and maintain expertise and training in Good Clinical Practice regulations


• Demonstrate superior knowledge of and be able to provide top level technical reviews of Good Laboratory Practices (GLP) reports, annual reports, and similar data for products in the FHP portfolio


• Ensure compliance of the FHP portfolio of Expanded Access protocols with all applicable FDA, DoD, and local regulations and requirements


• Review and analyze technical documents and make recommendations to ensure that sound scientific processes are used to support the Special Immunizations Program (SIP) portfolio of investigational vaccines. Ensure those processes and any deliverables meet all federal regulatory requirements for the use of investigational products


• Maintain current knowledge of relevant technology and industry developments


• Participate in special projects as required

Necessary Skills and Knowledge:

• Working knowledge of Current Good Manufacturing Practices (cGMP)
• Experience as a scientific subject matter expert, responding to technical and scientific questions and provide support of the review of regulatory requirements for product compliance, inventory management, archiving, and storage of vaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices
• Proven understanding of FDA rules and regulations regarding IND protocol submission, product compliance and management
• Working understanding of Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and
• Current Good Manufacturing Practices (cGMP)
• Strong oral and written communication skills
• Excellent organizational skills with the ability to coordinate multiple work streams, multi-task, and work well under tight deadlines
• Strong interpersonal skills and proven experience in building successful partnerships with business and technical groups

Minimum Qualifications:

• Masters’ Degree in science discipline such as virology or microbiology
• Minimum ten (10) or more years related experience in scientific knowledge in areas of infectious diseases, bio-threats or molecular diagnostics
• US Citizenship required
• Ability to obtain a NACI public trust

Preferred Qualifications:

• Doctoral Degree preferred

The salary range for this position is $156,000.00-$188,000.00 Annually.

Pay and Benefits

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.