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Research Specialist – PPK/PD

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Aug 6, 2022

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Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

Summary

This individual will serve as a contributor in the Preclinical Pharmacokinetics and Pharmacodynamics (PPK/PD) Group.  This individual will track project priorities for the group and provide logistical support (eg, drug product requirements) in support of PK studies at CROs, will work with the preclinical immunoassay group to ensure transparency of data transfer/sharing and will follow all SOPs to ensure GLP compliance. This person will contribute to the protocol design and study operations for all Pharmacokinetic/Toxicokinetic studies, and may support study data analysis using WinNonLin and other similar programs.

Job duties

  • Independently executes broad array of work supporting department priorities in routine Pharmacometrics deliverables on study design, data analysis and reporting.
  • Support CRO Studies, track study DS/DP requirements and track project priorities for the group
  • Performs descriptive data analyses for study reports and publications as applicable; may perform non-compartmental PK and compartmental PK/PD analyses, according to GxP as appropriate.
  • May provide PK data analysis to support BLA Filings
  • Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines

Requirements

  • Bachelor’s degree (B.S.) in biology or a related field from an accredited college or university with a minimum of two years of post-degree laboratory experience necessary
  • An understanding of pharmacokinetics concepts and techniques 
  • Experience in animal pharmacology, PK or TK studies, including protocol design & study conduct
  • Good time management skills to ensure that key data is turned around to meet critical deadlines
  • Good communication skills to ensure that key issues are brought to the attention of their supervisor
  • Interested in learning to use relevant software, including Phoenix WinNonLin
  • Experience in working in a GLP environment and following SOPs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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