Principal Research Associate/Toxicology Study Coordinator (Toxicology)

Location: Full-time, on-site in Carlsbad, California, United States

Salary: $110,847–$142,160 per year

Company

Ionis is a biotechnology and pharmaceutical company developing RNA-targeted medicines, gene-editing approaches, and therapies for serious diseases.

What you will do

• Plan, coordinate, and oversee nonclinical GLP and non-GLP toxicology studies conducted through CROs and, when applicable, in-house.
• Review protocols, amendments, deviations, study updates, data, and draft reports for completeness, accuracy, and consistency.
• Organize and summarize toxicology data, identify trends or inconsistencies, and prepare tables, figures, presentations, and study summaries.
• Coordinate study quotations, timelines, test articles, formulations, sample shipments, milestones, budgets, and report delivery.
• Facilitate collaboration among CROs, toxicology, pathology, DMPK, bioanalytical, manufacturing, quality, regulatory, finance, legal, and project management teams.
• Support investigative studies, regulatory documentation, operational processes, templates, tracking systems, and electronic records.

Requirements

• BS or MS in Toxicology, Biology, Pharmacology, Veterinary Science, Life Sciences, or a related discipline.
• At least 8 years of relevant experience in the pharmaceutical, biotechnology, or CRO industry.
• Experience managing nonclinical toxicology studies conducted at CROs.
• Working knowledge of GLP requirements and nonclinical drug development processes.
• Strong organization, attention to detail, communication, and multitasking skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Nice to have

• Experience with JMP, project-management tools, databases, or electronic document systems.

Culture & Benefits

• On-site work environment focused on scientific excellence, innovation, and collaboration.
• Opportunity to contribute to programs addressing serious diseases and unmet patient needs.
• Benefits package offered.
• Equal employment opportunity workplace.