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Clinical Pharmacologist Investigator III

Company: Kikiktagruk Inupiat Corporation
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

Title: Clinical Pharmacologist - Investigator III

Location: Silver Spring, MD

FLSA Status: Exempt

Full- Time Position


Position Summary:

Midnight Sun Technologies is looking to hire a Pharmaceutical Specialist - Investigator III.

Pharmaceutical Science Services to Provide Support for the Generic Drug User Fee Amendments (GDUFA)- funded Regulatory Science Research Program; Data Science Services to Provide Support for the Generic Drug User Fee Amendments (GDUFA)- funded Regulatory Science Research Program; Mechanistic Modeling Services to Provide Support for the Generic Drug User Fee Amendments (GDUFA)-funded Regulatory Science Research Program; Interdisciplinary Scientist for Modeling and Evaluation of Opioid Products; Pharmacology or Biopharmaceutical Services to Provide Support for the Generic Drug User Fee Amendments (GDUFA)- funded Regulatory Science Research Program.

BE testing for complex generic drugs is a complex and challenging issue, which may hinder the development of generic drugs. The GDUFA regulatory science priority list highlights the importance of novel bioequivalence methods and tools that will allow FDA to address these challenges and help in providing timely guidance to generic drug industry which may help in increasing access to affordable medicines to American public. A pharmaceutical scientist (e. g, a pharmacometrician, clinical pharmacologist, data scientist, or chemical engineer with relevant experience in life science) with expertise in pharmacometrics, quantitative clinical pharmacology is needed to support the development of novel BE pathways.

Duties/Responsibilities:

  • To develop databases for meta-analysis of chosen drug class (anti-coagulants/ Asthma/chronic obstructive pulmonary disease)
  • To conduct meta-analysis on the overall benefit risk profiles of the chose drug class in terms of exposure-response relationships for efficacy and safety
  • To perform simulations to evaluate the scientific performance of current BE standards for the class of drug products
  • To perform simulations and data analysis to support and evaluate innovative BE study pathways.
  • Compile a large database incorporating data including in vivo PK and in vivo therapeutic effect for assigned products with the same therapeutic target.
  • Conduct meta-analysis based on the exposure response relationship for studied drug efficacy and safety using common endpoints; normalize the established exposure-response to assess the existence of universal benefit-risk profiles models.
  • Assess of the performance of currently recommended BE standards for the evaluated products from an overall benefit/risk profile and propose new approach based on the need.
  • Preform simulations and data analysis to support and evaluate innovative BE pathways.

Minimum Requirements:

  • Preferred of an MS and 10+ years of experience or PhD and 5+ years of experience.
  • Advance understanding about scientific research business processes and all matters related to this area
  • Must be able to obtain/maintain an FDA security clearance

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.

Keywords: Kikiktagruk Inupiat Corporation, Silver Spring , Clinical Pharmacologist Investigator III, Other , Silver Spring, Maryland

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