BARDA Senior Clinical Studies Program Manager

Company Description

BryceTech 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. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran

Job Description

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  

Program Manager Responsibilities - General. 

• Provide concept ideas for BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN),et al].

• Review and advise on contract proposals (formally and informally submitted), as requested.
• Provide project development level portfolio management and oversight.
• Provide program level portfolio management and oversight.
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
• Assist in contract negotiations on technical matters, as requested.
• Deliver briefings on relevant subject matter for ASPR/BARDA Senior Leadership and serve as scientific and technical representative for the Program Office(s) concerning the project management of the advanced development, licensure, and acquisition(s) of medical countermeasures, including regulatory and clinical pathways and establishment of manufacturing capacity.

Clinical Studies Program Manager Specific Responsibilities

• Supervisor for multiple Clinical Studies Program Managers.
• Primary point of contact for BARDA senior and executive leadership on clinical study matters.
• Develop and execute long-term strategic plans to achieve organizational goals, including developing a strategic plan for the entire department or team.
• Establishing standards for performance and measuring progress towards goals, then communicating results to stakeholders.
• Determining how best to allocate resources across multiple projects or initiatives based on available funding and personnel.
• Analyzing data to identify problems and propose solutions.
• Develop and implement processes and procedures to ensure efficiency and consistency in operations.
• Oversee the section of participants to reporting of the clinical trial process including establishing protocols, determining which tests to perform and how frequently to administer them to meet specific scientific standards and government regulations.
• Participate in tactical and strategic program/project development and planning.
• Participate in program/project budget development processes and regularly reviews to ensure alignment.
• Lead and participate in program/project start up and close out functions.
• Liaise and coordinate with a variety of program/project stakeholders including, but not limited to, program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff.
• Develop, review, maintain regulatory and other program/project documentation.
• Assist with Material Transfer Agreements, Data Use Agreements and Research Collaboration agreements.
• Ensure program/project compliance with Food and Drug Administration (FDA) and other regulatory bodies.
• Coordinate site visits and other meetings with key stakeholders.
• Develop and maintain a variety of reports and communicate and present data to stakeholders.
• Develop and implement community outreach and engagement initiatives.
• Assist in