Senior Surgical Trauma & Critical Care? supporting Clinical Sciences and Medical Product Development SME | Healthcare and Life Sciences [HHS126031]

Senior Surgical Trauma & Critical Care? Supporting Clinical Sciences and Medical Product Development SME | Healthcare and Life Sciences

ProSidian is seeking a Senior Surgical Trauma & Critical Care? supporting Clinical Sciences and Medical Product Development SME for a full-time position in the Healthcare and Life Sciences sector. This role is based in Washington DC and across the Mid Atlantic region, supporting advanced scientific professional staffing services in the medical countermeasures field of research and development.

This position is an exempt full-time role with ProSidian, offering competitive benefits and salary. The candidate will provide services and support as a subject matter expert in the fields of chemical, radiological/nuclear, burn and blast injuries, biological threats, influenza, and emerging infectious diseases. The role involves supporting the Biomedical Advanced Research and Development Authority (BARDA) in the research, development, manufacture, and regulatory approval of medical countermeasures.

Responsibilities and Duties:

• Support BARDA Program Office(s) as a subject matter expert in various medical threat areas.
• Provide guidance and recommendations on key issues related to medical countermeasures.
• Serve as advisor(s) on Technical Evaluation Panels.
• Participate as subject matter experts on Program Coordination Teams.
• Provide expert assessments, recommendations, and guidance to federal staff.
• Review and comment on study protocols, study reports, regulatory documents, and proposals.
• Develop work products including expert summary reports, analysis reports, and manuscript writing.
• Advise federal staff on the appropriateness and probability of success of contractor proposed statements of work.
• Experience distilling complex information into informative and concise summaries.
• Participate in strategic discussions to build new program areas in alignment with BARDA's mission space.
• Provide recommendations for project development level portfolio management and oversight.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
• Provide health economic perspective to support for BARDA input in ASPR planning efforts for incident response for material threat incidents.
• Provide SME support in publications and management of information on websites as required.

Qualifications:

• Medical degree (MD/DO) and completed postgraduate training in Surgery, Trauma, and Critical Care.
• At least 15 years of clinical practice, surgical and/or pharmaceutical industry experience.
• Extensive training in surgical trauma, critical care, and biologic/therapeutic product development.
• Proven experience in managing interdisciplinary teams in medical product development.
• Experience in public health service settings, exercises, or response activities is an advantage.

Education / Experience Requirements / Qualifications:

• MD/DO degree with specialization and completed postgraduate training in Surgery, Trauma, and Critical Care.
• Broad-based knowledge of medical device and biologics/therapeutics product development processes.
• Knowledge of intellectual property, the U.S. regulatory approval process, and public health frameworks.

Skills Required:

• Extensive clinical and surgical experience in trauma and critical care.
• Expertise in biologics, therapeutics, and medical device product development.
• Strong understanding of the U.S. regulatory approval process.
• Ability to review and synthesize complex clinical data, study protocols, and regulatory documents.
• Strong ability to provide clear and concise summaries of data to aid in decision-making.
• Experience with public health service activities and exercises.

Competencies Required:

• Ability to lead and contribute to cross-functional teams for program/project management in clinical product development.
• Strong problem-solving and analytical skills, particularly in complex and multidisciplinary projects.
• Excellent communication skills to present clinical and technical findings to both technical and non-technical stakeholders.
• Expertise in assessing surgical trauma and critical care trends and their implications for medical product development.
• Ability to guide decision-making processes with respect to preclinical and clinical data.

Ancillary Details Of The Roles:

• Provide subject matter expertise in clinical trials, trauma management, and critical care to BARDA's program offices.
• Support in the management and oversight of medical countermeasure development, including diagnostics, therapeutics, and medical devices for chemical, biological, radiological, and nuclear (CBRN) threats.
• Serve as an advisor on technical panels, including reviewing white papers, technical proposals, and budget proposals.
• Guide preclinical and clinical study designs to ensure they meet regulatory and scientific standards.
• Contribute to the development and implementation of clinical product development plans in line with BARDA's strategic goals.
• Review and evaluate RFPs, proposals, study protocols, and reports.
• Provide recommendations on Total Life Cycle Cost (TLCC) for development projects.
• Help guide federal staff in ASPR planning and response efforts for material threat incidents.
• Provide SME input for publications and assist with managing information on BARDA-related websites.

Other Details:

• Senior SMEs must possess leadership experience in clinical sciences and medical product development, with a demonstrated track record in the trauma and critical care field.
• The role may require involvement in federal response efforts and coordination with other agencies during public health emergencies or material threat incidents.
• The ability to synthesize complex medical and scientific data into actionable recommendations for federal program teams is essential.
• Experience in post-award contract management and evaluation is beneficial.

ProSidian Consulting values teamwork, leadership, business acumen, communication, motivation, agility, judgment, and organization. The ideal candidate will also demonstrate curiosity, humility, and a willingness to learn and grow.

ProSidian offers a comprehensive benefits package including competitive compensation, group medical, dental, and vision health insurance benefits, 401(k) retirement savings plan, vacation and paid time-off, pre-tax payment programs, purchasing discounts, security clearance, employee and contractor referral bonus program, performance incentives, flexible spending account, supplemental life/accidental death and dismemberment insurance, and short- and long-term disability insurance.