ProSidian Consulting
Senior Nonclinical Models SME | Healthcare and Life Sciences
ProSidian Consulting, Washington, District of Columbia, us, 20022
Senior Nonclinical Models SME | Healthcare and Life Sciences
ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. We help forward thinking clients solve problems and improve operations. Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes. Our Services are deployed across the enterprise, target drivers of economic profit (growth, margin and efficiency), and are aligned at the intersections of assets, processes, policies and people delivering value. Job Description
ProSidian Seeks a Senior Nonclinical Models SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Subject Matter Expert Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. Seeking Senior Nonclinical Models SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Senior Nonclinical Models SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World). RESPONSIBILITIES AND DUTIES
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Senior Nonclinical Models SME | Healthcare and Life Sciences [HHS118023] 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 the following areas are desired: 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). Qualifications
Desired Qualifications For Senior Nonclinical Models SME | Healthcare and Life Sciences [HHS118023] (HHS118023) Candidates: At least 15 years of relevant industry or professional experience. Extensive expertise in leading and managing nonclinical programs and research related to CBRN and public health threats Education / Experience Requirements / Qualifications 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) Skills Required 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 Competencies Required 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 Ancillary Details Of The Roles Deliverables include supporting BARDA's mission by guiding and overseeing nonclinical development projects. Involvement in the design, execution, and evaluation of nonclinical studies to support FDA regulatory approvals for medical countermeasures (MCMs) Active participation in strategic discussions for portfolio development and alignment with BARDA's mission space. Provide expertise in improving Total Life Cycle Cost (TLCC) efforts and participating in market research efforts Other Details Senior SMEs are expected to provide advanced leadership, expertise, and oversight for complex projects. Extensive understanding of the challenges and opportunities in developing MCMs for BARDA-related threats is highly desirable
ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. We help forward thinking clients solve problems and improve operations. Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes. Our Services are deployed across the enterprise, target drivers of economic profit (growth, margin and efficiency), and are aligned at the intersections of assets, processes, policies and people delivering value. Job Description
ProSidian Seeks a Senior Nonclinical Models SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Subject Matter Expert Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. Seeking Senior Nonclinical Models SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Senior Nonclinical Models SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World). RESPONSIBILITIES AND DUTIES
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Senior Nonclinical Models SME | Healthcare and Life Sciences [HHS118023] 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 the following areas are desired: 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). Qualifications
Desired Qualifications For Senior Nonclinical Models SME | Healthcare and Life Sciences [HHS118023] (HHS118023) Candidates: At least 15 years of relevant industry or professional experience. Extensive expertise in leading and managing nonclinical programs and research related to CBRN and public health threats Education / Experience Requirements / Qualifications 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) Skills Required 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 Competencies Required 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 Ancillary Details Of The Roles Deliverables include supporting BARDA's mission by guiding and overseeing nonclinical development projects. Involvement in the design, execution, and evaluation of nonclinical studies to support FDA regulatory approvals for medical countermeasures (MCMs) Active participation in strategic discussions for portfolio development and alignment with BARDA's mission space. Provide expertise in improving Total Life Cycle Cost (TLCC) efforts and participating in market research efforts Other Details Senior SMEs are expected to provide advanced leadership, expertise, and oversight for complex projects. Extensive understanding of the challenges and opportunities in developing MCMs for BARDA-related threats is highly desirable