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Job Description
Associate Director, Toxicology Ionis Pharmaceuticals, Inc. - 3.8 Carlsbad, CA Job Details $172,501 - $255,000 a year 1 hour ago Qualifications FDA submissions Project timeline management Investigational new drug (IND) applications Pre-clinical study projects Pharmaceutical company experience Compliance documentation Regulatory submission editing and review Communication with regulatory authorities for clinical trials Safety and toxicology data reporting Project leadership Project stakeholder communication Cross-functional communication Toxicology research projects Scientific reports Full 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!
ASSOCIATE DIRECTOR, TOXICOLOGY SUMMARY
Ionis is seeking a talented and highly motivated Toxicologist to join the Preclinical Development Department and provide scientific leadership in the nonclinical safety assessment of drug candidates. The department is composed of highly collaborative scientists and offers a supportive environment that fosters professional growth and continuous learning. The expectation will be for this person to work on site in Carlsbad, CA.
RESPONSIBILITIES
Serve as the nonclinical safety representative on cross-functional project teams, providing strategic toxicology input to support candidate selection, risk assessment, and program advancement Design, oversee, and interpret non-GLP and GLP nonclinical pharmacology and toxicology studies Manage outsourced toxicology studies at CROs, including study design, protocol and report review, issue resolution, and timeline management Drive integrated nonclinical safety assessments by synthesizing pharmacology, toxicology, clinical pathology, and TK/PK data Develop nonclinical toxicology and regulatory strategies for assigned programs Author and review nonclinical sections of regulatory documents, including Investigator's Brochures, INDs, NDAs, DSURs, and related submissions, and represent Ionis in interactions with regulatory authorities Assess toxicology findings and mechanisms of toxicity to determine human relevance and development impact Communicate key nonclinical safety findings, risk assessments, and development implications to project teams and governance committees Partner effectively with internal functional teams and external collaborators to advance programs in a matrixed development environment Represent Ionis externally through scientific meetings, industry consortia, working groups, and professional societies Contribute to scientific publications in high-impact, peer-reviewed journals
REQUIREMENTS
Master's or Doctoral degree in Toxicology or a related life sciences discipline At least 8 years (Master's degree) or 5 years (Ph.D.) of experience in nonclinical safety within the pharmaceutical or biotechnology industry. Experience managing outsourced studies and working with CROs, including protocol and report development or review, as well as timeline management Experience generating, integrating, reviewing, and interpreting toxicology data Experience authoring regulatory documents such as IBs, INDs, CTDs, and other health authority submissions Demonstrated ability to work effectively as a senior individual contributor in a matrixed environment, influencing without direct authority across scientific and functional teams Proven ability to convey advanced scientific information and persuade diverse stakeholders, including project teams, senior leadership and governance committees Commitment to lifelong learning and professional development, including building or expanding subject matter expertise
PREFERRED
DABT certification, or a strong interest in obtaining DABT certification Please visit our website, http://www.ionis.com (http://www.ionis.com) for more information about Ionis and to apply for this position; reference requisition #
IONIS004030
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits)
Full Benefits Link:
https://ionis.com/careers#:~:text=Highly%20competitive%20benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits) The pay scale for this position is $172,501 to $255,000 NO
PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
