PK / PD / TOXICOLOGY SUBJECT MATTER EXPERT

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 :

Requirements :

Additional Information

All your information will be kept confidential according to EEO guidelines.

Direct Staffing Inc

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