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