USAMMDA Team Lead – Program Management Support for Warfighter Brain Health

19 May 2024

Vacancy expired!

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 Team Lead for Warfighter Brain Health (WBH) PMO shall monitor operational day-to-day activities of other WBH Support and serve as the SME on WBH related tasks.  The team lead shall coordinate coverage for WBH Support as well as provide training and oversee the established USAMMDA processes, procedures, and standardization of WBH 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 Brain Health (WBH) specific support:  Develop statistical models using clinical and biological data that will inform clinical trial design (e.g., overall design schema, sample size calculations, screening, randomization, inclusion/exclusion criteria, etc.) in support of the USAMMDA PMOs.   Provide subject matter expertise, and work with regulatory scientists and clinical trial management teams as needed.   Support the review of documents and develop written documentation to aid in the Government’s understanding and oversight of the development and execution of clinical research and associated initiatives. Skills and Experience:  Capability to design and implement adaptive and innovative clinical trial designs, including Bayesian approaches used in platform trial designs, using biomarkers, including those derived from positron emission tomography (PET) imaging, functional and structural magnetic resonance imaging (MRI), electroencephalogram (EEG), and genetics/genomics.  Understanding of medical product development, with expertise in pharmaceutical development in the disease areas of psychiatry or neurology preferred. 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.   

  • ID: #49966533
  • State: Maryland Frederick 21701 Frederick USA
  • City: Frederick
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2023-05-19
  • Deadline: 2023-07-18
  • Category: Et cetera