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General.  The Team Lead provides Program/Project Management Support to the USAMMDA Organization within the realm of the WPAC mission space. The Team Lead for Warfighter Protection & Acute Care (WPAC) PMO shall monitor operational day-to-day activities of other WPAC Support and serve as the SME on WPAC related tasks.  The Team Lead shall coordinate coverage for WPAC Support as well as provide training and oversee the established USAMMDA processes, procedures, and standardization of WPAC tasks.   Organization Wide Support: Support the organization in the day-to-day medical product development activities according to U.S. Army, USAMRDC, USAMMDA, and DoD acquisition policies and regulations.  Participate in Integrated Product Team (IPT), Working Group, Product Lifecycle Review Committee (PLRC), and Investigator meetings; as well as other meetings that are part of the acquisition process including, but not limited to, In Process Reviews and Milestone Reviews. Develop and improve USAMMDA’s processes for acquisition planning, milestone and documentation preparation, and reporting. Support development of templates, Standard Operating Procedures, and checklists for acquisition processes. Conduct analysis of policy and guidance to identify impacts and opportunities related to USAMMDA’s acquisition programs.   Program Support: Prepare and maintain project management integrated master schedules, Gantt charts, and action item lists for assigned programs, based on input from the organization, outside consultants, and key USAMRDC staff according to project management best practices and DoD guidelines to monitor program progress.   Edit and maintain technical, budget, programmatic, administrative, and acquisition milestone documentation, to include program briefings IAW applicable DoD 5000 series regulations to ensure successful decision reviews, such as Business Case Analysis (BCA), Strategy Plans, Integrated Program Summary, Life Cycle Cost Estimates (LCCEs), Test and Evaluation Master Plans (TEMPs), and operating and maintenance instructions, considering elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework). Support the development of technology transition strategies, integrated risk assessments, and tailored acquisition strategies, program briefings, integrating the unique aspects of medical product development with the DoD acquisition processes.   Employ effective risk management practices in support of the program acquisition strategy.   Coordinate and conduct site visits (e.g. clinical, vendors, testing facilities, manufacturing facilities).   Coordinate the conduct of developmental testing as well as support and coordinate operational assessment and testing, to include delivery of test items such as test articles and manuals. Internal Project Management: Communicate and coordinate with internal and external stakeholders to meet program objectives and shall document their coordination; including the achievement of concurrence and/or non-concurrence with comment as directed by USAMMDA.   Assist in coordinating any needed support agreements with extramural customers, DoD stakeholders, or commercial entities.   Populate and maintain tracking of action items/taskers for specified product development programs according to DoD, Army, USAMRDC, and USAMMDA policies and procedures.   Monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate. Follow established industry best practices to determine the effectiveness of current operational activities and to determine problem areas and develop solutions.   Use the USAMRDC electronic document management system (EDMS)/LiveLinksystems.   Manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.   Copy files from network servers to their corresponding location within Opentext Livelink and/or MS Sharepoint.  Organize and prepare for meetings, schedule teleconferences, create and distribute agendas, create meeting minutes to include draft/final minutes, and deliver assessments in the form of information products including packages and briefings to the organization. Test and Evaluation: Provide support for all testing as well as all FDA and non-FDA regulated events.  Monitor the progress of clinical projects and provide recommendations on impact to acquisition strategies, maturity and risk of technologies, ability to address capability gaps for the focus areas for further development and/or investment. Support the clinical projects to ensure the Grants Officer Representative and/or COR has auditable clinical tracking and status reports and meets acquisition regulatory requirements. Technology Assessment: Conduct market research, support analyses, review existing tech base programs, and recommend acquisition strategies to strengthen and engage medical requirements and/or medical capabilities in support of force health protection and provide information packages based on the results of these analyses.   Participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment.   Support the management and execution of product evaluations and responses for the New Products and Ideas submissions.   Support management of the progress of projects/products and provide recommendations on acquisition strategies, maturity, and risk of technologies, assess capability gaps for the focus areas for further development and/or investment. Warfighter Protection and Acute Care (WPAC) Specific Support:  Apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for FHP missions.   Work with the USAMRDC Office of Regulatory Activities (ORA) to develop necessary regulatory documentation, organize, Provide annual and refresher Good Clinical Practices (GCP) training to medical and laboratory staff that provide patient care and oversee product management and accountability for FHP products and protocols. GCP training shall be written, web-based, electronic, and other easily exportable forms of instruction and meet requirements for Graduate Medical Education approval.  Provide training on IND products, man-made threats, and endemic diseases.  The training shall cover therapeutic use of the IND products and will be presented to appropriate DoD medical personnel in domestic and overseas locations.  The Contractor shall participate in IPT and working group meetings as required. Coordinate with multiple stakeholders to gather and analyze technically complex information, project management of therapeutics, prophylactics, diagnostics, and management of clinical trials.   Review and analyze technical documents and make recommendations to ensure that sound scientific processes are used to support the portfolio of investigational products and that those processes and any deliverables meet all federal regulatory requirements for the use of investigational products.  Coordinate meetings, lead working groups, develop and/or edit meeting minutes, develop technical reports, and assist with other tasks and deliverables as required to provide support to the FHP Directorate.   Work with USAMRDC ORA for ensuring IND protocols met all regulatory requirements, such as supporting submission of documents for FDA approval to gain FDA approval.   Interact with SMEs, USAMRDC IRB, along with local reviewing IRBs, to gain IRB approval.  Provide storage, protocol management, and product issue for FHP IND products entrusted to their care.   Research, develop, and write content for printed manuals, protocols, documentation, and supporting materials. Prepare written documents following standard guidelines for technical publications. Review, edit, and proo materials written by others. Apply knowledge in the area of DoD acquisition, force health protection, and clinical/ FDA regulatory product development to vaccine technology and drug treatment therapies for infectious diseases of military relevance, and/or chemical and biological defense medical countermeasures, and/or regenerative medicine and/or blood and blood products and other combat casualty care products or devices and/or post-traumatic stress disorder and traumatic brain injury and/or clinical and regulatory support. Skills and Experience: Apply interpersonal skills and knowledge of the DoD 5000 to products being supported.   Integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process.  Expert level knowledge of Joint Capabilities Integration and Development System (JCIDS); PPBE; and DoD 5000 processes, including adaptive acquisition framework pathways, to support strategic analysis and acquisition planning for Army and DHA ACAT designated medical programs.   Utilize MS Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word, at an intermediate level. Personnel performing in this task area shall be capable of understanding Current Good Clinical Practice (cGCP), Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP), to apply knowledge of FDA requirements and procedures, especially Title 5 Code of Federal Regulations (CFR) regulations concerning IND protocols.