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!
EXECUTIVE DIRECTOR, PATHOLOGY AND NONCLINICAL DRUG SAFETY This position will have oversight for anatomic and clinical pathology that is part of the safety evaluation of multiple drug candidates. This will include primary histopathology and peer review of critical studies. There will also be involvement in design and interpretation of toxicology studies to support drug development, preparation of toxicology summaries for regulatory documents, and the successful submission and maintenance of IND/IMPD and CTD submission. This position will also contribute strategically to the Ionis Development organization. The expectation will be for the candidate to be on-site at the Headquarters in Carlsbad, CA.
RESPONSIBILITIES: - Provide scientific and regulatory leadership within the Toxicology department and Development Management Committee.
- Establish, manage and refine the infrastructure for pathology assessment internally at Ionis and at CRO's.
- Conduct primary histopathology and pathology peer review for critical development studies, as needed.
- Interact with partners and regulators to explain and educate on pathology assessment.
- Interaction with Toxicology management and Study Directors, as well as a multidisciplinary team outside of the Toxicology Group (the "Project Team" which includes Research, Pharmaceutical Development, Analytical Development, Regulatory Affairs, Drug development, and Clinical Operations personnel) to provide needed data and coordinate activities.
- Foster partnership with Regulatory Affairs.
- Conduct gap analyses and safety reviews of drug candidates to facilitate successful progression of development programs.
- Contribute to preparation of Development plans.
- Contribute to regulatory strategy and documents to support the initiation of clinical trials and drug registration (IB, IND, IMPD, Annual Reports, CTD, etc.).
- Consult on the design and interpretation of toxicology studies.
- Provide mentoring and coaching to Pathologists and Project Toxicologists with respect to regulatory interactions and document preparation.
- Provide sound multi-disciplinary experience on Research Toxicology (i.e., identifying mechanisms of action and species specificity of class related toxicities).
- Interface with external advisors and regulatory agencies.
- Establish collaborations with specific academic laboratories expert in particular fields of interest.
- Publish and present findings at scientific meetings.
REQUIREMENTS: - DVM, PhD board certified in pathology
- 10+ years of experience in pharmaceutical or biotech industry
- Experience with multiple regulatory submissions and interactions
- Proven effective management and leadership skills
- History of successful research and problem solving
Please visit our website, for more information about Ionis and to apply for this position; reference requisition #IONIS003712
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis Benefits Full Benefits Link:
The pay scale for this position is $305,000 to $378,000
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 notice from the Department of Labor. Ionis
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