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Senior Pharmacometrics Scientist (Europe, remote-based)

  • Location: France
  • £ Salary: Negotiable per year
  • Job Type:Permanent

Posted about 2 months ago

  • Sector: Life Sciences
  • Contact: Christian Garrett
  • Expiry Date: 14 February 2024
  • Job Ref: JN -122023-483029

Job responsibilities:

  • Provide PK and PKPD input into study design, study protocol, and statistical analysis plan of clinical pharmacology as well as phase II-III studies for all projects
  • Perform PK non-compartmental analysis (NCA)
  • Write PK and PKPD sections of Clinical Study Reports and pharmacometrics reports according to EU and US guidelines
  • Write Data Analysis Plan for the pharmacometrics analyses (PopPK, PBPK, QSP)
  • Build the data set for PKPD analyses and relative quality checks
  • Perform exploratory analysis of PK and clinical data as well as clinical trial simulation
  • Develop semi-mechanistic and mechanistic pharmacometrics models aimed at evaluating the exposure-response relationship
  • Write and review regulatory submission documents
  • Act as Clinical Pharmacologist in compliance with internal procedures and regulatory requirements
  • Responsible for PKPD tasks of the clinical phase I-III trials for the assigned projects

Requirements:

  • 3+ years' experience in topics related to PK, ADME, and clinical pharmacology
  • Deep experience performing hands-on PKPD modelling
  • Hands-on expertise with NONMEM, Monolix, or R
  • Fluent in English

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