Temporary Toxicology Operations Associate

Ionis Brand; Carlsbad (CA); On-site; USD 55,000 - 72,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, seeks a Temporary Toxicology Study Coordinator to join the nonclinical Toxicology team. You will serve as the primary liaison between Ionis, CROs, and internal teams to ensure smooth study conduct.

The role is fast-paced and cross-functional, requiring strong organizational, multitasking and communication skills. This 100% on-site position supports study coordination activities in Carlsbad.

Qualifications

• Bachelor's degree in biology or related science field required with 5+ years relevant experience.
• Nonclinical study conduct experience required.
• Proficiency with Microsoft Office applications; strong organization, multitasking and communication.

Responsibilities

• Facilitate study contracts (SOWs), protocols and reports.
• Review study protocols, reports and amendments.
• Track milestones using in-house database for finance updates.
• Coordinate sample shipments and maintain Chain of Custody.
• Prepare and distribute data templates.
• Maintain study outlines templates.
• Provide general assistance to Ionis Scientists.
• QC reports, data tables and regulatory submission docs.
• Plan and manage a diverse workload.
• Schedule meetings and prepare minutes.
• Provide general operational support (ELN, file systems).

Skills

MS Office

Communication

Organization

Multitasking

Education

Bachelor's degree in biology or related science

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!

Temporary Toxicology Study Coordinator

Hiring Manager: Christine Hoffmaster - Onsite, Carlsbad

We are seeking a highly organized and detail-oriented professional to join our Toxicology team as a 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. At Ionis, we are committed to fostering a diverse and inclusive workplace where all individuals are valued, respected, and empowered to contribute their unique perspectives.

The Study Coordinator role is a fast-paced, cross-functional, vital role in the smooth execution of Ionis nonclinical study conduct. Study Coordination and Operational Responsibilities include:

• Facilitation of study contracts (SOWs), protocols, reports, etc.
• Test article and formulation requests, review of study protocols, reports, amendments, etc
• Track and maintain study specific milestones using in-house database in support of 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 outlines templates
• General assistance to Ionis Scientists will be an essential part of the role and additional non study specific support may be required across departments
• QC reports, data, data tables, presentations, documents for regulatory submissions (eg IND, IB, NDA, etc) using advanced functions of MS Word, Excel and e-sub compliance software, as appropriate.
• Plan, prioritize, and manage a diverse workload with associated responsibilities
• Schedule and participates in department and study-related meetings, as required, prepare meeting minutes.
• General operational support including document processing (e.g., ELN, study tracker management, etc), maintaining file systems for accuracy and completeness, invoice review and approval,

REQUIREMENTS:

A bachelor’s degree in biology or a related science field is required along with a minimum of 5 years relevant experience. Experience in nonclinical study conduct is required.

Strong candidates must be highly proficient with Microsoft Office applications, possess excellent organizational, multitasking, and communication skills. The ability to work both independently and collaboratively is essential. The ideal candidate will also demonstrate flexibility and adaptability in a dynamic, team-oriented environment.

Please note: this position is 100% on-site.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Reference Requisition #TEMPO004001

The hourly pay scale for this position is $39.73/hour to $52.48/hour

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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