has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision making. Bryce cultivates a culture of engagement and partnership with our clients. Bryce Space and Technology is an Equal Opportunity Employer.
BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.
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.
The Contractor will 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.
The Contractor will provide subject matter expertise, and work with regulatory scientists and clinical trial management teams as needed.
The Contractor will 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.
Personnel performing in support of WBH PMO in this task area will have the 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.
Personnel performing in this task area will also have an understanding of medical product development, with expertise in pharmaceutical development in the disease areas of psychiatry or neurology preferred.
Related Program Support Skills
The Contractor will provide Program/Project Management Support to USAMMDA within the realm of the DoD’s acquisition process.
The Contractor will apply pertinent laws, regulations, policies, procedures, and work processes to requirements involving the major issues and goals and objectives for product development.
The Contractor will 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.
The Contractor will 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.
The Contractor will 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.
The Contractor will coordinate and conduct site visits (e.g. clinical, vendors, testing facilities, manufacturing facilities).
The Contractor will 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.
The Contractor will 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.
The Contractor will 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. In development of these documents the Contractor will consider elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework).
The Contractor will communicate and coordinate with internal and external stakeholders to meet program objectives and will document their coordination; including the achievement of concurrence and/or non-concurrence with comment as directed by USAMMDA. The Contractor will assist in coordinating any needed support agreements with extramural customers, DoD stakeholders, or commercial entities.
The Contractor will populate and maintain tracking of action items/taskers for specified product development programs according to DoD, Army, USAMRDC, and USAMMDA policies and procedures.
The Contractor will monitor, coordinate, and report responses to external requests and tasks for information, ensuring responses are timely and accurate.
The Contractor will follow established industry best practices to determine the effectiveness of current operational activities and to determine problem areas and develop solutions.
The Contractor will employ effective risk management practices in support of the program acquisition strategy.
The Contractor will 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.
The Contractor will use the USAMRDC electronic document management system (EDMS)/LiveLinksystems. The Contractor will manage the electronic filing, maintenance, and recovery of all program documentation on existing electronic records management systems.
The Contractor will copy files from network servers to their corresponding location within Opentext Livelink and/or MS Sharepoint.
The Contractor will provide support for all testing as well as all FDA and non-FDA regulated events.
The Contractor will 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.
The Contractor will 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.
The Contractor will 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.
The Contractor will participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment.
The Contractor will support the management and execution of product evaluations and responses for the New Products and Ideas submissions.
Personnel performing in this task area will have the ability to apply interpersonal skills and knowledge of the DoD 5000 to products being supported. Personnel performing in this task area will have the capability to utilize MS Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word, at an intermediate level. In addition, personnel performing in this task area will have the capability of developing and updating schedules, as well as assist in the development of LCCEs.
The Contractor will provide the capability of integrating the DoD acquisition processes with the FDA regulatory processes and the Environmental Protection Agency (EPA) process. It is desired that the Contractor provide the capability to apply DoD acquisition integration to specific developmental technologies including, vaccine technology and drug treatment therapies for infectious diseases of military relevance; 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 medical support system and evacuation products and/or systems; and/or clinical and regulatory support.
Education: Bachelor’s Degree in Mathematics or Related Field
Experience: 10 years’ experience
Duty: This position is Remote. The Contractor can expect to work at the government’s facility on occasion.
Investigation Type: T1
IT/ADP Level: Level 3
Security Clearance: N/A
Travel: Local Travel Only is Anticipated