Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
Intellia is looking for a Director of PreClinical Genomics to support the advancement of genome editing products into the clinic. Within this leadership role, you will be responsible for the implementation and execution of on-target and genotoxicity data packages enabling in vivo and cell therapy program progression into clinical trials. You will be responsible for the documentation enabling regulatory filings including data documentation and quality control. This is a highly visible leadership position serving on multiple therapeutic program teams supporting regulatory filings and documentation. In this role you will:
Manage a team of molecular biologists focused on the execution of genotoxicity data packages in support of regulatory filings and clinical programs
Transition genomic assays from research into development through optimization and validation to apply to regulatory programs implementing SOPs, standards, etc
Oversee data quality and writing of technical reports, genotoxicity addendums, briefing books, INDs, CTAs and other requests from global regulatory authorities
Partner with computational biology, software engineering, and PreClinical Project Management on data analysis, data capture, and documentation
Partner with Genomic Innovation to develop and align on- and off- target and genomic characterization assays to support pipeline programs and platform technology
Serve as SME for genotoxicity assessment in support of in vivo and cell therapy development program advancement to the clinic
Partner with PreClinical in vitro pharmacology on strategy for in vitro sample preparation in support of genotoxicity assays
Effectively interact with other functional area experts in a program team environment to execute on the best course of action for genotoxicity assessment
Partner with Toxicology on strategy and guidance for genotoxicity assessment for gene editing approaches
Work with PreClinical Project Management to align resources and timelines
Partner with regulatory, clinical, and program team leads to support regulatory filings
Support the development of direct reports through coaching, mentoring, leveraging their strengths, and providing opportunities for career growth
The Director of PreClinical Genomics will have demonstrated expertise in NGS and other sequencing methodologies, molecular biology, gene editing approaches and experience in supporting gene editing therapies to the clinic including engaging with health authorities both written and verbally.
Ph.D. with 10 years directly related industry experience.
Experience managing a high-performing team in a fast-paced environment.
Experience juggling multiple high-priority projects and balancing resources.
Experience in writing and documentation to support regulatory filings as well as response to health authority questions and interacting with health authorities.
Meet your future team:
You will be an SME for genotoxicity and gene editing products working closely with PreClinical in vitro pharmacology, Computational Biology, Toxicology, Genomics Innovation and PreClinical Project Management to support the development of genome editing-based therapeutics into the clinic. We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials.
In this key leadership role, you will report directly to the Vice President, Genomic Operations, who instills a culture of teamwork, respect, inclusion, collaboration, and communication ensuring that each team member strives to reach their professional and personal potential.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.