PRINCIPAL RESEARCH ASSOCIATE/ TOXICOLOGY STUDY COORDINATORSUMMARY:This position is responsible for planning, coordinating, and overseeing nonclinical toxicology studies supporting discovery, IND-enabling, and post-marketing programs. The individual will ensure that studies are conducted with appropriate quality, GLP compliance, scientific rigor, and alignment with program timelines. Responsibilities also include reviewing, organizing, and summarizing study data, and providing study updates to project teams and other internal stakeholders. This position reports to the Vice President of Toxicology and works closely with toxicologists and the Toxicology Operations team to coordinate study activities, support data review, and address departmental operational priorities. This is a full-time, on-site position based in Carlsbad, CA.
KEY RESPONSIBILITIES:Scientific and Development Responsibilities
- Establish and maintain regular communication with study directors and other scientific personnel at contract research organizations (CROs).
- Review study protocols, protocol amendments, deviations, study updates, data, and draft reports for completeness, consistency, and accuracy.
- Organize, review, and summarize toxicology study data and identify trends, inconsistencies, or potential findings for discussion with the responsible toxicologist and study team.
- Prepare data summaries, tables, figures, and presentations for toxicology and project team discussions.
- Assist toxicologists with the review and preparation of study summaries and supporting materials for regulatory documents, including IBs, INDs, annual reports, CTDs, NDAs, and other submissions.
- Support investigative studies designed to better understand unexpected findings, mechanisms of toxicity, species specificity, or potential safety implications, as needed.
Operational Responsibilities
- Serve as study coordinator for non-GLP and GLP toxicology studies conducted at CROs and, as applicable, in-house.
- Coordinate study quotations, protocol outlines, study timelines, test article and formulation requests, sample shipments, and other study start-up activities.
- Track study milestones, budgets, data delivery, report timelines, and outstanding action items.
- Coordinate the shipment and receipt of test articles, formulations, biological samples, and study-related materials.
- Facilitate communication among CROs, toxicologists, pathology, DMPK, bioanalytical, manufacturing, quality assurance, regulatory, finance, legal, and project management groups.
- Assist with the collection, compilation, quality review, and presentation of study data and reports.
- Maintain toxicology study tracking systems, databases, files, and electronic records for accuracy and completeness.
- Support the development and improvement of toxicology operational processes, templates, and study management tools.
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. Equivalent combinations of education and experience may be considered.
- Experience managing nonclinical toxicology studies conducted at CROs.
- Working knowledge of GLP requirements and nonclinical drug development processes.
- Strong organizational skills, attention to detail, and the ability to manage multiple studies and priorities simultaneously.
- Strong written and oral communication skills and demonstrated ability to work effectively with internal teams and external vendors.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat. Experience with JMP, project-management tools, databases, or electronic document systems is preferred.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004062
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $110,847 to $142,160
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
