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Toxicologist
Rockville, MD

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My biotech client is expanding and seeks a preclinical scientist to take on the following tasks:

  • Serve on project teams focused on developing novel therapeutic drugs and targets.
  • Act as the scientific and technical reviewer for nonclinical studies performed with external collaborators or CROs.
  • Write and edit nonclinical study protocols.
  • Oversee review of nonclinical study reports and finalize study reports to ensure appropriate interpretation and reporting of data.
  • Build and develop partnerships with CROs.
  • Write and review nonclinical safety documentation, including IBs, INDs and BLAs.
  • Communicate with regulatory agencies to resolve nonclinical issues.

 

The ideal candidate will possess the following qualities:

  • MS/PhD and 2+ years of toxicological related sciences in academia or industry setting.
  • Experience in organizing, analyzing, and documenting nonclinical studies.
  • Ability to organize and analyze multidisciplinary data sets.
  • Available to travel to CROs for study monitoring activities.
  • Working knowledge of regulatory guidelines relevant to preclinical development.
  • Understanding of FDA and GLP.


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