- Contributes to the overall toxicology strategy for one or several Research and Development programs, throughout the drug development lifecycle
- Interacts with other functional area experts in a project team environment to recommend the best course of action for a given program, and defend those recommendations to internal governance committees
- Scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies; serve as study monitor and/or peer review pathologist; prepared to support the execution of each study
- Reviews study designs and ensures interdependencies (e.g., Bioanalytical, CMC and Quality and Clinical) are aligned with emphasis on the appropriate and efficient evaluation of pathology
- Represents Intellia on partnered programs and at external venues such as scientific meetings
- Succinctly and effectively summarizes the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols
- Interact with Health Authorities, in writing and verbally, including pre-IND or scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
- DVM/VMD and unrestricted licensure
- Board certification veterinary anatomical pathology or AP/CP
- Experience with ICH guided, GLP compliant nonclinical study design and conduct, including pathology peer review
- Experience managing multiple drug development programs and priorities, studies, external CRO management
- Solid understanding of molecular biology, genetics and immunology
- Board certifications in clinical pathology and/or toxicology provide additional consideration
- Expertise in immunotoxicology, immunogenicity, T cell biology
- Experience with lipid nanoparticle delivery of nucleic acid therapies
- Experience with development of Cell and Gene Therapy or ATMP products, and bioassay requirements
- Understanding of the evolving regulatory requirements for cell and gene therapy (CBER/OTAT) products in the US or ATMP products in Europe.
- Experience in oncology and/or rare disease drug discovery
- Prior experience in cell therapy preferred, though experience in other treatment modalities in oncology such as antibody therapeutics would also be valuable
- Detailed knowledge of cellular and/or tumor immunology principles, technologies, and experimental techniques (cell culture, in vitro cellular assays, flow cytometry)
- Expertise in functional assays measuring cellular activation, cytokine release, proliferation, and cell killing.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.