Associate Director, Toxicological Pathologist
- Employer
- Intellia Therapeutics
- Location
- Cambridge, MA, United States
- Start date
- Feb 12, 2021
View more
- Discipline
- Science/R&D, Pathology, Toxicology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.
Job Description:
Intellia Therapeutics is seeking to support an expanding development pipeline with scientists to characterize the safety of their innovative products. We are currently seeking an Associate Director to serve as Pathology Lead. Ideal candidates will be enthusiastic, entrepreneurial scientists motivated to shape how gene editing benefits patients. The successful candidate will have opportunities to lead basic research initiatives while gaining broad experience supporting nonclinical development of CRISPR/Cas9 products.
Responsibilities:
- 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.
Basic Qualifications:
- 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
Preferred Qualifications:
- 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.
LI#DG1
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.
Company
Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.
Change life stories with genome editing therapies!
Stock Symbol: NTLA
- Website
- http://intelliatx.com/
- Phone
- (857) 285-6200
- Location
-
40 Erie Street
Cambridge
Massachusetts
02139
United States
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