Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and high patient needs areas, we continue to drive innovation in RNA therapies and advance new gene editing approaches to provide greater value to patients. At Ionis, we cultivate a challenging, motivating environment that fosters innovation and scientific excellence, recognizing that our success depends on our talented and dedicated employees. We are committed to building a diverse team with varied skills and perspectives, investing in our onsite, hybrid, and remote work environments to foster strong relationships and a thriving culture. If you are passionate about making a meaningful impact on patients’ lives, we invite you to apply, contribute to our culture, and grow your career with us! EXECUTIVE DIRECTOR, PATHOLOGY AND NONCLINICAL DRUG SAFETY This role oversees anatomic and clinical pathology within the safety evaluation of multiple drug candidates, including primary histopathology, peer review, and involvement in toxicology study design and interpretation. Responsibilities include preparing toxicology summaries for regulatory submissions, supporting IND/IMPD and CTD maintenance, and strategic contributions to the Ionis Development organization. The candidate must be on-site at our headquarters in Carlsbad, CA. RESPONSIBILITIES: Provide scientific and regulatory leadership within the Toxicology department and Development Management Committee. Manage infrastructure for pathology assessment internally and at CROs. Conduct primary histopathology and peer review for critical studies. Engage with partners and regulators to explain pathology assessments. Collaborate with Toxicology management, Study Directors, and multidisciplinary teams to provide data and coordinate activities. Foster partnerships with Regulatory Affairs. Perform gap analyses and safety reviews to facilitate development progress. Contribute to development and regulatory submission plans and documents. Advise on toxicology study design and interpretation. Mentor and coach pathology and toxicology staff on regulatory interactions and documentation. Provide expertise on research toxicology mechanisms and species specificity. Engage with external advisors and regulatory agencies. Establish collaborations with academic laboratories. Publish and present scientific findings. REQUIREMENTS: DVM or PhD in pathology, board certified. 10+ years in pharma or biotech industry. Experience with regulatory submissions and agency interactions. Proven leadership and management skills. Successful research and problem-solving track record. Visit to learn more and apply, referencing requisition #IONIS003712. We offer an excellent benefits package. Details available at Ionis Benefits . Salary range: $305,000 to $378,000.
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