Associate Director of Pathology

Role Summary

Associate Director of Pathology within the Preclinical Development Department, responsible for strategic scientific leadership in the assessment of nonclinical safety of candidate medicines. Collaborates with cross-functional teams to design nonclinical studies, provide regulatory input, and communicate findings to governance bodies and external stakeholders.

• Conduct histopathology review of internal and outsourced non-GLP and GLP research, pharmacology, and toxicology studies and provide interpretation that integrates all study data
• Serve as nonclinical safety representative on cross-functional project teams based on interest
• Contribute to the design of non-GLP and GLP nonclinical studies
• Provide strategic input on the nonclinical toxicology and regulatory approach for IND-enabling packages and for clinical stage programs
• Author nonclinical sections of regulatory documents (e.g. IB, IND, NDA, DSUR, etc) and represent Ionis in meetings with regulatory authorities
• Assess mechanism(s) of toxicity to determine clinical relevance and impact
• Communicate pathology and nonclinical safety findings, interpretation, and impact to teams and governance committees
• Represent Ionis externally (e.g. at scientific meetings and/or through participation in industry consortia, working groups, and/or professional societies)
• Publish findings in high impact peer-reviewed journal

• Required:
  
  DVM (or equivalent)
• Required:
  
  PhD in pathology, toxicology, or related life sciences discipline
• Required:
  
  Board-certification in anatomic pathology (e.g. ACVP, ECVP)
• Required:
  
  At least 5 years of experience in toxicologic pathology of multiple species in the pharmaceutical or biotechnology field with a focus on IND-enabling packages and beyond
• Preferred:
  Experience with digital pathology and image analysis
• Required:
  
  Experience with regulatory submissions and interactions
• Required:
  
  Demonstrated strong decision-making and problem-solving skills
• Required:
  
  Team player with proven interpersonal and communication skills
• Required:
  
  Dedication to lifelong learning and professional development

• DVM (or equivalent)
• PhD in pathology, toxicology, or related life sciences discipline
• Board-certification in anatomic pathology (e.g. ACVP, ECVP)