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)
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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)
#J-18808-Ljbffr