Tunnell Consulting

Receive alerts when this company posts new jobs.

Similar Jobs

Job Details

Animal Models Subject Matter Expert

at Tunnell Consulting

Posted: 9/20/2019
Job Reference #: 9307
Keywords: animal, veterinary

Job Description

Job Title: Animals Models Subject Matter Expert (SME) for CBRN, Influenza, and Emerging Infectious Disease Medical Countermeasure (MCM) Development

Primary skills:

  • 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.

 

Primary responsibilities: 

  • 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.

 

Requirements:

  • 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