Ionis is seeking a talented and highly motivated Toxicologist to join the Preclinical Development Department and provide scientific leadership in the nonclinical safety assessment of drug candidates. The department is composed of highly collaborative scientists and offers a supportive environment that fosters professional growth and continuous learning.
The expectation will be for this person to work on site in Carlsbad, CA.
- Serve as the nonclinical safety representative on cross-functional project teams, providing strategic toxicology input to support candidate selection, risk assessment, and program advancement
- Design, oversee, and interpret non-GLP and GLP nonclinical pharmacology and toxicology studies
- Manage outsourced toxicology studies at CROs, including study design, protocol and report review, issue resolution, and timeline management
- Drive integrated nonclinical safety assessments by synthesizing pharmacology, toxicology, clinical pathology, and TK/PK data
- Develop nonclinical toxicology and regulatory strategies for assigned programs
- Author and review nonclinical sections of regulatory documents, including Investigator's Brochures, INDs, NDAs, DSURs, and related submissions, and represent Ionis in interactions with regulatory authorities
- Assess toxicology findings and mechanisms of toxicity to determine human relevance and development impact
- Communicate key nonclinical safety findings, risk assessments, and development implications to project teams and governance committees
- Partner effectively with internal functional teams and external collaborators to advance programs in a matrixed development environment
- Represent Ionis externally through scientific meetings, industry consortia, working groups, and professional societies
- Contribute to scientific publications in high-impact, peer-reviewed journals
- Master’s or Doctoral degree in Toxicology or a related life sciences discipline
- At least 8 years (Master’s degree) or 5 years (Ph.D.) of experience in nonclinical safety within the pharmaceutical or biotechnology industry. Experience managing outsourced studies and working with CROs, including protocol and report development or review, as well as timeline management
- Experience generating, integrating, reviewing, and interpreting toxicology data
- Experience authoring regulatory documents such as IBs, INDs, CTDs, and other health authority submissions
- Demonstrated ability to work effectively as a senior individual contributor in a matrixed environment, influencing without direct authority across scientific and functional teams
- Proven ability to convey advanced scientific information and persuade diverse stakeholders, including project teams, senior leadership and governance committees
- Commitment to lifelong learning and professional development, including building or expanding subject matter expertise
- DABT certification, or a strong interest in obtaining DABT certification
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004030