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Animal Models Subject Matter Expert
at Tunnell Consulting
Job Title: Animals Models Subject Matter Expert (SME) for CBRN, Influenza, and Emerging Infectious Disease Medical Countermeasure (MCM) Development
- Advanced degree in veterinary medicine, microbiology, toxicology, pharmacodynamics, pharmacokinetics, pharmacology, immunology, biochemistry, pathophysiology, systemic biology, or another related field.
- Wide range of non-clinical drug development expertise, extensive knowledge and experience developing and applying animal models and in vitro assays:
- Animal Model Development: More than ten years of experience specifically related to developing animal models to support U.S. FDA licensure of medical countermeasures for biological, chemical, and/or radiological/nuclear threats.
- Expertise in the design and execution of non-clinical studies in various animal species including rodents, swine, rabbits, and non-human primates.
- Knowledgeable in the pathophysiological mechanisms of toxicity or virulence, host susceptibility and response, and establishing comparability between animal species and humans.
- Specific experience conducting in vivo studies that demonstrated drug efficacy in animals expected to react with a response predictive of humans preferred to include the application of bioanalytical assays.
- Primary Pharmacodynamics: Experience in managing the technical aspects of in vitro and in vivo studies pertaining to the mechanism of action and PK/PD, modeling and simulation, and optimal dose/dosing regimen selection.
- Experience working with or in managing the contracting with Contract Research Organizations (CRO).
- Experience working in a regulatory science environment, including knowledge of current FDA and ICH guidance as they pertain to drug development.
- Previous training and experience in conducting studies in accordance with GLP regulations.
- Participation as a team member in the regulatory submissions of INDs, NDAs, BLAs or PMAs to the FDA (CDER, CBER and CDRH); successful filings (licensing and approvals) a plus.
Provide strategic, technical and operational Project Management leadership to Preclinical Development (PCD) and Drug Safety & Pharmacometrics (DSP).
Influence project teams on operational and strategic areas of increasing complexity to ensure that programs are driven to completion.
Provide strategic and operational Project Management leadership and support to cross-functional or cross-departmental teams for multiple programs or projects of moderate to high complexity. Influences program strategy, goals and plans
Independently applies technical knowledge (scientific, drug development and/or project management) to drive development and implementation of new and unique concepts, techniques and standards
- Support the US government (USG) in awarding and funding contracts for the development of therapeutics and/or devices to be used as MCMs.
- Participate in Technical Evaluation Panels for whitepapers and proposals submitted to the USG for funding.
- Participate in the development of Statements of Work (SOWs) and Technical Evaluation Criteria which will be useful to the USG in making appropriate selections.
- Support the USG by providing technical expertise to individual Project Core Teams (PCTs).
- Participate in PCTs for the assigned contracts.
- Partner with PCTs to identify and resolve any project performance issues. Provide recommended solutions to identified problems.
- Attend PCT meetings, and site visits as required.
- Review PCT agendas, meeting minutes, meeting materials, and other administrative reports.
- Review the overall project plan for the development of an individual MCM, including the overall work plan, human/technical resources, costs, and overall regulatory strategy for attaining licensure.
- Review study plans, protocols, study results, reports, and regulatory submission documents.
- Conduct gap analysis in area of expertise.
- Review PCT progress reports and provide comments on potential technical issues, cost questions, and program gaps.
- Understand and apply the FDA’s “animal rule” and pre- Emergency Use Authorization (EUA)
- Manage non-clinical aspects of a broad range of advanced research & development and procurement projects from early stage through post-approval.
- Provide support to BARDA’s animal model and non-clinical development efforts.
- An advanced graduate degree is required (PhD) in microbiology, biochemistry, pathophysiology, molecular medicine, systemic biology, pharmacology, pharmacokinetics or another related field; additional DVM degree is desirable.
- At least 15 years pharmaceutical industry experience, with a minimum of 10 years experience specifically related to the advanced development of medical countermeasures (ie vaccines and therapeutics) against chemical, biological, radiological and nuclear threat agents.
Possess a wide range of development expertise in all aspects of medical countermeasures development (preferred) OR non-clinical medical countermeasures development expertise, with extensive knowledge and experience developing and applying animal models and appropriate in vitro assays.
- Demonstrated hands-on experience in the management of contractors and subcontractors such as CROs
Experienced in the analysis of Advanced Research & Development data, gap analysis, and critical evaluation of whitepapers and proposals for new medical countermeasure projects.
Proactively identifies areas of increasing complexity (operational and/or strategic) and identifies innovative solutions and approaches for process improvement. Independently develops and gains alignment on solutions. Drives implementation of solutions of moderate to high complexity.
At times, may provide operational and/or strategic Project Management support to specific selected initiatives within PCD and/or DSP.
Possess an appreciation of the challenges associated with the advanced development of medical countermeasures for chemical, biological, radiological and nuclear threats as demonstrated by the individual’s work experience.
Direct experience in CBRN is a plus.
Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge of shared work environments.
Be recognized as an authority in animal models and drug development, as evidenced by:
Publications and/or invited presentations to industry symposiums/conferences
Positions held in companies with successful track records in MCM product development and commercialization programs.
Committee membership / leadership in recognized industry organizations