Executive Director, Pathology and Nonclinical Drug Safety

Role Summary

Executive Director, Pathology and Nonclinical Drug Safety. This position oversees anatomic and clinical pathology within the safety evaluation of multiple drug candidates, including primary histopathology and pathology peer review of critical studies. Involves design and interpretation of toxicology studies to support drug development, preparation of toxicology summaries for regulatory documents, and submission and maintenance of IND/IMPD and CTD submissions. On-site at Ionis Headquarters in Carlsbad, CA.

Responsibilities

• Provide scientific and regulatory leadership within the Toxicology department and Development Management Committee.
• Establish, manage and refine the infrastructure for pathology assessment internally at Ionis and at CROs.
• Conduct primary histopathology and pathology peer review for critical development studies, as needed.
• Interact with partners and regulators to explain and educate on pathology assessment.
• Collaborate with Toxicology management, Study Directors, and a multidisciplinary Project Team to provide data and coordinate activities.
• Foster partnership with Regulatory Affairs.
• Conduct gap analyses and safety reviews of drug candidates to facilitate development progression.
• Contribute to preparation of Development plans.
• Contribute to regulatory strategy and documents to support initiation of clinical trials and drug registration (IB, IND, IMPD, Annual Reports, CTD, etc.).
• Consult on the design and interpretation of toxicology studies.
• Provide mentoring and coaching to Pathologists and Project Toxicologists regarding regulatory interactions and documentation.
• Provide multidisciplinary experience on Research Toxicology (mechanisms of action and species specificity of class-related toxicities).
• Interface with external advisors and regulatory agencies.
• Establish collaborations with academic laboratories in specialized fields.
• Publish and present findings at scientific meetings.

Qualifications

• DVM or PhD, board certified in pathology
• 10+ years of experience in the pharmaceutical or biotech industry
• Experience with multiple regulatory submissions and interactions
• Proven effective management and leadership skills
• History of successful research and problem solving