Non-Clinical Advisor (Animal Models) JVAP Ft. Detrick MD

Job Location
Frederick, MD
Salary
Negotiable
Benefits

The Tauri Group offers competitive salary and benefits package including 401(k) with employer match, medical, dental, and vision insurance.  EEO employer.  To find out more about use please visit our website at:  www.TauriGroup.com

 

Job Description

Non-Clinical Advisor (Animal Models)

Joint Vaccine Acquisition Program (JVAP)

Ft. Detrick MD

The Tauri Group

 

The Tauri Group, an innovator in analytical consulting, applies creative, responsive problem solving to homeland security, defense, and space enterprises. Government agencies and multinational contractors trust our objectivity and vision. They know we bring the leading minds in homeland security, technology, aerospace, arms control, public health, and more to tackle issues with no easy answers. Our projects are at the forefront of today's world of security, defense, science, and technology.

We are looking for a Non-Clinical Advisor for advising and providing detailed guidance in the oversight of the technical development of preclinical and IND-supporting studies to support development and eventual licensure of advanced vaccine development programs. The Advisor will provide detailed guidance on suitability nonclinical efficacy studies to support product development through to licensure via the US FDA's "Animal Rule".

Requirements

Responsibilities:

Performs a leadership role, problem-solving technical issues related to non-clinical studies and communicating solutions and emerging risks, accurately and timely, to  project management leadership and senior executives

•  The Advisor will review and provide guidance on the technical requirements for non-clinical studies to assure an effective development strategy, and, through the Vaccine Manager, manage the risks and impacts on program cost, schedule and performance.

Works with Integrated Process Teams (comprised of Government civilians, military and non-Government personnel, and matrix support staff with diverse areas of expertise, to include program managers, budget analysts, regulatory specialists, acquisition analysts, and logisticians) interact directly with individual Vaccine Managers to communicate study updates and facilitate problem solving and appropriate data analysis.

•  Works with diverse product development teams, to include Government personnel and other performers, such as statisticians, biologists, toxicologists, clinicians, pharmacologists, and formulation scientists

 

•  Represents the organization, communicating with individuals both in and outside the organization, to include customers, the public, and other Government agencies and external sources

•  Interprets data and designs subsequent experiments with minimal oversight in support of non-clinical testing of vaccines under the Animal Rule

•  Reviews all aspects of testing and data analysis in order to generate detailed and well-documented recommendations to be provided as guidance for a path forward

• Assesses technical maturity of immunological assays as it relates to bridging animal and human clinical data

•  Performs data-level technical and quality reviews of non-clinical results (i.e., pathology reports, assay results, and implications/interpretations) to ensure: o Technical and scientific data integrity

o  Assures adherence to compliance with appropriate regulatory standards

Provides consultation to clients in the design of experimental studies and protocols, interpretation of experimental results, review of study reports, and recommendations from other performer(s)

•  Authors, edits, and contributes to technical reports (e.g., overall project concepts and descriptions, test plans, etc.)

• Interprets the meaning of information for others, to include:

• Translating or explaining what the information means and how it can be used

• Generating, interpreting, and communicating results from in vivo pre-clinical/non-clinical studies to teams of biochemists, biologists, pharmacologists, program managers, and non-scientists)

• Reviews other performer contractor’s implementation of activities to ensure they are in compliance with good laboratory practices, standard operating procedures, protocols, and regulations related to ethics and animal welfare

  • Ensures experimental data are being properly collected

  • Properly  documents deviations to protocol should they occur

  • Participates in audits as needed

    • Maintains current technical knowledge and skills, applying them to the job as necessary

    • Maintains communication with supervisors, peers, or subordinates via telephone, e-mail, or in person, as required

    • Develops and maintains constructive and cooperative working relationships with others

     

     

     

    Education:

    The candidate shall possess a PhD in Chemistry, Biology, Immunology, or a DVM -AND- 8+ years of Industry experience in pharmaceutical**/biotechnology advanced development (i.e., IND to FDA approval)

    • Alternate Education: The contractor shall possess a Master’s Degree in Chemistry, Biology, Immunology -AND- 15+ years of Industry experience in pharmaceutical**/biotechnology advanced development (i.e., IND to FDA approval)

    The Advisor must have demonstrated pharmaceutical experience by providing evidence of patents achieved or multiple publications authored in peer-reviewed journals.

How to Apply

 

To apply, please forward your resume along with a cover letter outlining your experience and salary expectations to:  [email protected]

About Our Organization

The Tauri Group, an innovator in analytical consulting, applies creative, responsive problem solving to homeland security, defense, and space enterprises. Government agencies and multinational contractors trust our objectivity and vision. They know we bring the leading minds in homeland security, technology, aerospace, arms control, public health, and more to tackle issues with no easy answers. Our projects are at the forefront of today's world of security, defense, science, and technology.

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