Toxicology Study Director

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  • Leading Toxicology organisation
  • Madrid based opportunity
  • Excellent career opportunities
  • Multiple projects and studies

We are looking to recruit a Study Director for a progressive preclinical drug development organisation in Madrid.  Due to expansion, we require an experienced Study Director to be fully responsible for GLP compliance within studies, having responsibility for organising and coordinating the tasks of a toxicology and safety study in the pharmaceutical and biotechnology industry.

Key responsibilities:

  • Define the aim of the study plan according to the information presented by business development department and study monitor / sponsor.
  • Approve the study plan which is prepared before study initiation by dated signature.
  • Report to the study monitor / sponsor on the condition of the study plan.
  • Coordinate with the delegated phases the deadlines for the reports.
  • Follow the indications of the quality assurance unit.
  • Coordinate with the technical director of the study time schedule according to the SOP in place.
  • Train and involve to the staff of a study in the aims of the same one and critical points of bearing in mind.
  • Ensure test and reference item are properly characterised, identified, used and stored.
  • Take a constant follow-up carried out by the personnel involved in the study. Checking the raw data acquisition, test procedure.
  • Attend and solve incidents that happen along the study.
  • Periodic communications with the study monitor / sponsor and submit interim reports.
  • Ensure that computerized systems are suitable for their intended purpose, have been validated, and are fit for use in the study.

Key requirements:

  • Proven experience as a Study Director within a toxicology, preclinical or safety sector
  • Life sciences degree