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Clinical Pharmacologist/part time

Company: LanceSoft, Inc.
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Title: Clinical PharmacologistDuration: 5 monthsLocation: Cambridge, MA 02142
100% REMOTE10 hours per week (with flexibility to increase as needed)Timings: 08 AM to 11 AM This contractor will serve as a back up to the internal FTE on projects. Job Description:This individual will support the PK/PD aspects of clinical studies (from protocol to CSR) and related regulatory submission activities. This role requires a strong pharmacokinetics/pharmacodynamics/pharmacometrics knowledge.
Job Responsibilities:

  • Support PK/PD aspects of clinical studies, including synopsis/protocol development, statistical analysis plan and clinical pharmacology data analysis plan review, TLF shell and dry-run reviews, and CSR.
  • Oversee relevant PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.
  • Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings.
    Qualifications:Minimum Education Requirement
    • A Ph.D. or equivalent degree with at least 5 years of experience OR an MS or equivalent degree with at least 10 years of experience, where experience means having a proven track record within the duties mentioned above in pharmaceutical industry, regulatory agency, or academia.
      Required Experience and Skills:
      • Educational background in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or a related field.
        Excellent verbal and written communication skillsDetail-oriented skills

Keywords: LanceSoft, Inc., Cambridge , Clinical Pharmacologist/part time, Healthcare , Cambridge, Massachusetts

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