Job Description

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 select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

PRINCIPAL RESEARCH ASSOCIATE/ TOXICOLOGY STUDY COORDINATOR

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 Benefits

Full 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.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.