PK/PD/Toxicology Subject Matter Expert (SME) for CBRN, Influenza and Emerging Infectious Disease Medical Countermeasure (MCM) Development
Primary skills:
Academic (research and publications) and Practical (licensing, applied science and experience) traits include : Animal sciences background: wide academic and industrial drug development background using large and small animal models and also genetically modified animals; knowledge of immunology and general pathology
Drug development pharmacology testing: drug binding assays, pharmacokinetic modeling and parameter estimations, pharmacodynamic testing; efficacy models. Drug development toxicology testing: Study design and execution experience (i.e. acute and subacute studies; plus experience working with or in contracting CROs); knowledge of genotoxicology; cardiovascular physiology testing; neurologic testing, hematologic and physiologic function testing; animal necropsy and histologic assessments.
Clinical science background: An understanding of clinical trial design, GCP, and site and data management; radiopharmaceutical drug development
Participation as a primary team member in the regulatory submissions of INDs, NDAs, BLA,s or PMAs to the FDA (CDER, CBER and CDRH); successful filings (licensing and approvals) a plus.
Primary responsibilities:
Pre-award activities for solicitations: Provide subject matter intelligence for the Contract Officer(s) (CO) on the appropriate pharmacology and toxicology studies, animal and clinical science models, analytical methods, regulatory approaches applicable to an indication and utility of MCMs
Develop initial SOWs and Technical Evaluation Criteria which will be useful in making appropriate USG MCM selections for a medical concern.
Provide product development cost analyses and generate formal independent government cost estimates (IGCE) for the CO
Participate in Technical Evaluation Panels (TEPs)
Participate in pre-award negotiations with the CO and PO for selection and design of studies to be performed, program cost analysis and appropriateness of timelines and project staffing and facilities.
Post-Award efforts for solicitations: Serve as an advisor in support of the Project Officer (PO) and support the CO in the conduct of contract support, i.e. weekly TCONs, site visits, review of documents, study designs, analytical approaches, animal models, etc
Support the scientific validity of proposed work and provide supportive solutions as a technical representative for the project to the PO for the CO.
Evaluate and comment on weekly TCON content and progress to the PO
Review monthly and quarterly progress reports and provide comment on study issues, cost questions and provide recommendations for solutions to identified problems.
General Responsibilities: Provide scientific and practical experience-based solutions to contract problems
Support the Project Officers in the conduct of Contract
Provide scientific support as needed to BARDA Senior Management
Support Project Officers, Project Managers and COs with technical briefings and educational support when needed and requested.
Requirements:
Minimum of 15 years of industry experience
Ph.D. or equivalent; M.S. acceptable with appropriate experience and professional licensing a plus
Professional publications related drug development
Industrial experience with regulatory filings a major plus;
Academic and professional peer recognition as an SME in toxicology or pharmacology.
All your information will be kept confidential according to EEO guidelines.
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