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Translational Scientist

Company: Job Juncture
Location: Philadelphia
Posted on: September 14, 2019

Job Description:

My client is expanding and looking to hire a Scientist for their development group. This is a high impact role - the ideal candidate will take on the following tasks:

  • Act as primary point of contact for PK/PD-related activities on preclinical and early clinical development programs
  • Manage analyses of PK/PD data, integrating preclinical study simulation strategies and informing of the relevant risk and benefit implications
  • Liaise with the preclinical and bioanalytical sciences team and regulatory in creating preclinical PK/TK written and tabulated summaries for IND and BLA applications
  • Collaborate within the development on the design and reporting of nonclinical safety studies and comply with GLP regulations for GLP studies
  • Perform PD, biodistribution and immunogenicity analyses for GLP studies, record data and analysis results in GLP-compliant manner, and ensure timely and clear communication with other groups

    The ideal candidate will possess the following qualities:

    • PhD in pharmacology, toxicology, biology, etc plus 3-5+ years of biotech industry experience.
    • Previous contributions to PK summaries for regulatory documents
    • Ability to maintain a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
    • Expertise with pharmacodynamics, biodistribution and immunogenicity assays
    • Expertise with PK software and modeling, including Winnonlin
    • Experience in animal PK/TK studies, including protocol design & study conduct
    • Experience in formulating hypothesis testing for early clinical studies, using in vitro and in vivo preclinical studies and patient samples.

Keywords: Job Juncture, Philadelphia , Translational Scientist, Other , Philadelphia, Pennsylvania

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