Toxicology/Director, Toxicology (Remote)
Remote Remote, WA Remote US
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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