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Background.  USAMMDA is the largest Department of Defense's (DoD) medical materiel development activity designed to protect and preserve the lives of Warfighters.  USAMMDA develops, modernizes, procures, and fields new drugs, vaccines, medical devices and support equipment that enhances readiness, ensuring the provision of the highest quality medical care to the DoD and maximizing survival of medical casualties on the battlefield.General.  The Contractor will provide expertise in the areas of devices, diagnostics, vaccine technology, therapeutics (e.g. drugs, immunotherapy, etc.) drug treatment therapies, and entomology solutions for infectious diseases of military relevance; and/or other medical countermeasures, and/or regenerative medicine; and/or blood and blood products/components and other combat casualty care products or devices; and/or post-traumatic stress disorder and traumatic brain injury. The Contractor will provide clinical management expertise for both DoD-sponsored and non-DoD-sponsored clinical research activities. Activities include but are not limited to:  serving as a SME involved in the initial planning and development of the contract management plan; planning, designing, coordination, management, and conduct of clinical trial research, to include but not limited to protocols; assist in the writing and preparation of clinical protocols and other clinical trial documents; serve as a key member of IPT; provide expertise to aid in the development of the research strategy for clinical trials; provide subject matter expertise in clinical trial site selection, site set-up, and subject recruitment and retention; provide subject matter expertise to Project Manager (PjM)/Product Manager (PdM) regarding site investigator selection and issues related to clinical trial staff training; provide input on issues related to local clinical trial site administrative and operational issues, including the preparation of clinical trial agreements and site- and study-specific document. The Contractor will attend and participate in site visits, IPT meetings and briefings, and sub-working group and investigator meetings. The Contractor will orchestrate the requisite regulatory strategy as well as organization and compliance activities as contained in USAMRDC regulations, policies, pamphlets, and SOP.The Contractor will interact with USAMMDA, USAMRDC, and other Government Agencies to assist in identifying, interpreting, prioritizing, and analyzing FDA, CFR, DoD, DA, USAMRDC policies, regulations, and guidance documents as they relate to products in different stages of development. The Contractor will coordinate and assist with Joint Trauma System (JTS) to develop Clinical Practice Guideline(s) in support of the full rate decision or off-label use of the materiel solution. The Contractor will collaborate as necessary to identify regulatory affairs (RA) strategies that will optimize product development. The Contractor will review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data; facilitate an understanding of the requirements for compliance with all applicable FDA regulations. The Contractor will understand and plan for future clinical trials and other pre-clinical trial milestones; coordinate and assist in the review of all pre-clinical trial documents; and keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.  The Contractor will assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of devices, pharmaceuticals, and vaccines.  The Contractor will provide professional medical review of Investigational Device Exemption, IND protocols, IND packages, and plans for management of IND products. The Contractor will provide subject matter expertise in pharmaceutical quality/chemistry, manufacturing, and controls (CMC).  The Contractor will assess CMC related risk of commercial partners.  The Contractor will perform audits and provide GMP compliance advice. The Contractor will be a substantive participant in IPTs as a SME. The Contractor will provide expert written reviews, briefings, and recommendations for developmental medical projects to include reviewing and interpreting results.  At the end of data analysis, the Contractor will support scientific preparation of results for eventual publication in peer reviewed scientific journals or other media or publication.  The Contractor will provide a medical/expert review of documents that will be submitted to the FDA, EPA or other Governmental or Military organizations. The Contractor will provide manuscript reviews for documents/reports submitted to scientific journals.   Personnel performing in this task area will possess a medical degree and/or doctorate, or certification in a medical, scientific, or technical field related to medical product development.Personnel performing in this task area will have the capability of applying knowledge of the DoD’s acquisition process in conjunction with their expertise in performance of all tasks as stated above for the given clinical problem and relevant epidemiology.