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Toxicology/Director, Toxicology (Remote)

Remote, WA Remote

Posted: 08/26/2022 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 497735-1 Is job remote?: Yes Country: United States

Job Description


Key Responsibilities
  • Design, implementation, monitoring, data analysis and reporting of both investigative and regulatory nonclinical toxicology studies
  • Toxicology functional area representative on multidisciplinary project teams for pipeline and clinical stage programs
  • Ensure appropriate timeline management and scientific oversight of CROs for non-GLP and GLP compliant studies conducted externally
  • Willingness to implement and advance applications of digital pathology to make microscopic findings more readily accessible to non-pathology scientific staff
  • Review toxicology study reports including all data and interpretations of findings.
  • Prepare verbal and written summaries of data for presentation and communication with non-pathology scientific staff for internal discussions and decision making.
  • Contribute to various regulatory documents to support IND-enabling and clinical stage activities.

Education and Certification Requirements:
  • PhD. or equivalent in Toxicology, Pathology, or related health science field with working knowledge of clinical pathology strongly preferred
  • Certification by the American Board of Toxicology (DABT) desirable, particularly in the absence of a PhD
  • DVM is advantageous, but not required.

Qualifications and Experience:
  • A minimum of 5 years’ experience in the biotech/pharmaceutical industry or a CRO as study monitor or study director and preferably in the areas of new biologic therapies and or immune-oncology products
  • Working knowledge of GLP regulations, ICH and other regulatory guidance documents, and experience conducting, and monitoring toxicology studies are critical
  • Strong communication skills, both oral and written, at all levels inside and outside the organization are essential
  • Experience in supporting drug development teams and preparing IND filings is beneficial
  • Must be detail-oriented with strong documentation practices and organizational skills, with a commitment to quality and accountability
  • Proficient at working independently as well as in a collaborative team setting
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

 
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