Temporary Toxicology Operations Associate
About the Company
Headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that redefine 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 select areas of high patient needs, we drive innovation in RNA therapies and advance new approaches in gene editing. Ionis cultivates a challenging, motivating, and rewarding environment that fosters innovation and scientific excellence, valuing the exceptional talents and dedication of our employees.
About the Role
We are seeking a highly organized and detail-oriented professional to join our Toxicology team as a Temporary Toxicology Study Coordinator. In this cross-functional role, you will serve as the primary liaison between Ionis, our contract research organizations (CROs), and various internal teams. This position is 100% on-site in Carlsbad, California.
Responsibilities
- Facilitate study contracts (SOWs), protocols, reports, and related documents.
- Manage test article and formulation requests, review study protocols, reports, and amendments.
- Track and maintain study-specific milestones using an in-house database to support quarterly finance updates.
- Coordinate sample shipments, receipt, and transfer of sensitive study samples; maintain Chain of Custody.
- Prepare, review, and distribute data templates; maintain and update study outline templates.
- Provide general assistance to Ionis Scientists and support across departments as needed.
- Perform QC on reports, data, data tables, presentations, and documents for regulatory submissions (e.g., IND, IB, NDA) using MS Word, Excel, and e-sub compliance software.
- Plan, prioritize, and manage a diverse workload with associated responsibilities.
- Schedule and participate in department and study-related meetings; prepare meeting minutes.
- Provide general operational support, including document processing (e.g., ELN, study tracker management), maintaining file systems, and invoice review and approval.
Requirements
- A bachelor’s degree in biology or a related science field is required.
- A minimum of 5 years of relevant experience, including experience in nonclinical study conduct.
- High proficiency with Microsoft Office applications.
- Excellent organizational, multitasking, and communication skills.
- Ability to work both independently and collaboratively in a dynamic, team-oriented environment.
- Flexibility and adaptability to changing priorities.
Pay
The hourly pay scale for this position is $39.73/hour to $52.48/hour.