Full-Time
Senior Nonclinical Models SME
Healthcare and Life Sciences
Prosidian Consulting
11-50 employees
Management and operations consulting firm
No salary listed
Washington, DC, USA
In Person
Category
 Biology & Biotech (4) |
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Required Skills
Medicinal Chemistry
Microbiology
Pharmacology
Requirements
- Doctoral degree in biology, chemistry, pharmacology, or a similar field.
- Commensurate experience in nonclinical development areas, including animal models, bioanalytical assays, and regulatory pathways (e.g., Animal Rule).
- Knowledge of FDA approval or licensure pathways (for example, the Animal Rule).
- Expertise in developing animal models for predictive human responses.
- Experience in conducting in vivo studies and applying bioanalytical assays.
- Strong knowledge of chemical, biological, radiological, or nuclear threat related nonclinical research.
- Ability to guide and monitor research with Contract Research Organizations (CROs).
- Proficiency in managing programs within BARDA’s nonclinical contracts and task orders.
- Strong analytical skills for evaluating and advising on preclinical and nonclinical development projects.
Responsibilities
- Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
- Candidates with experience in medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning).
- Provide guidance and recommendations on key issues related to the area(s) identified above.
- Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
- Participate as subject matter experts on Program Coordination Teams (PCTs)
- Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed
- Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
- Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
- Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
- Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
- Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
- Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
- Provide recommendations for project development level portfolio management and oversight as required.
- Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
- Provide nonclinical development subject matter expertise support throughout various programs within BARDA for MCM development.
- Provide subject matter expertise in developing animal models to support U.S. FDA approval or licensure of MCMs for biological, chemical, and/or radiological/nuclear threats (e.g., Animal Rule pathway).
- Provide subject matter expertise conducting in vivo studies that demonstrate drug efficacy in animals expected to react with a response predictive of humans preferred to include the application of bioanalytical assays.
- Provide support to BARDA’s nonclinical development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).
Desired Qualifications
- At least 15 years of relevant industry or professional experience.
- Extensive expertise in leading and managing nonclinical programs and research related to chemical, biological, radiological and nuclear threats.
- Doctoral degree in biology, chemistry, pharmacology, or a similar field.
- Commensurate experience in nonclinical development areas, including animal models, bioanalytical assays, and regulatory pathways (e.g., Animal Rule)
- Knowledge of FDA approval/licensure pathways (e.g., Animal Rule pathway).
- Expertise in developing animal models for predictive human responses.
- Experience in conducting in vivo studies and applying bioanalytical assays.
- Strong knowledge of CBRN-related nonclinical research.
- Ability to guide and monitor research with Contract Research Organizations (CROs).
- Proficiency in managing programs within BARDA’s nonclinical contracts and task orders.
- Strong analytical skills for evaluating and advising on preclinical and nonclinical development projects.
ProSidian Consulting provides management and operations consulting to private companies, Fortune 1000 enterprises, and government agencies. It uses industry-aligned services across six practice areas: Risk Management, Energy & Sustainability, Compliance, Business Process, IT Effectiveness, and Human Capital, delivered by multidisciplinary teams. The firm connects strategy to execution with On-Demand Resources and targets drivers of economic profit—growth, margin, and efficiency—across assets, processes, policies, and people. Its goal is to help leaders design and execute operations that increase value for customers and improve return on invested capital.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Charlotte, North Carolina
Founded
2008
Simplify's Take
What believers are saying
- Remote-first model attracts talent nationwide, cuts office overhead costs.
- Energy & Sustainability practice meets tightening ESG mandates for Fortune 1000.
- Human Capital solutions address 2025-2026 retention, skills gaps challenges.
What critics are saying
- Deloitte poaches Big 4 alumni, erodes 190-professional talent pool in 6-12 months.
- Stagnant website since 2020 loses clients to Booz Allen in 3-6 months.
- No alliances post-2013 isolates energy bids against EY networks in 6-12 months.
What makes Prosidian Consulting unique
- On-demand model deploys experienced-only Big 4 alumni for rapid execution.
- Multidisciplinary teams span Risk Management, Energy & Sustainability, Compliance.
- Structured approach links strategy to execution across assets, processes, people.
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