Title: Clinical Pharmacologist - Investigator III
Location: Silver Spring, MD
FLSA Status: Exempt
Full- Time Position
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
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.
To develop databases for meta-analysis of chosen drug class
(anti-coagulants/ Asthma/chronic obstructive pulmonary
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
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.
Preferred of an MS and 10+ years of experience or PhD and 5+ years
Advance understanding about scientific research business processes
and all matters related to this area
Must be able to obtain/maintain an FDA security
online at our website: https://kikiktagruk.applicantpool.com/
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.