Nonclinical Operations Lead

Cambridge, MA, United States
May 26, 2021
Required Education
Bachelors Degree
Position Type
Full time
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 At Intellia :

Intellia Therapeutics is seeking to support an expanding development pipeline with scientists to characterize their innovative products. Ideal candidates will be enthusiastic, highly organized and motivated to shape how CRISPR/Cas9 gene editing benefits patients. The successful candidate will have opportunities to work with principal investigators to manage complex nonclinical activities while gaining broad experience in product development in an industry environment.

  • Effectively initiate, manage, and track all aspects of definitive nonclinical (nonGLP and GLP) cell therapy and genome editing studies
  • Oversee qualification and selection of nonclinical CROs to support the nonclinical development program in collaboration with functional leaders (e.g., Bioanalytical, Toxicology, TechOps, Quality)
  • Develop SOWs and obtain quotes from CROs for pending nonclinical studies or support services
  • Work with Finance, Procurement and Legal business partners to ensure CDA/NDA, MSA, SOW, POs and budget are in place and tracked properly
  • Calculate and coordinate test article needs, coordinate across multiple departments for study support such as sample analyses (e.g., bioanalytical, TechOps, pathology)
  • Oversee and monitor external nonclinical studies to ensure proper dosing, execution and close of study activities, and generate monitoring reports for internal and QA review
  • Formally summarize study designs and activity timelines for presentation at internal group, department, or program team meetings
  • Summarization of key data in collaboration with principal investigator(s); perform data review/verification, document generation, document management and cross-referencing as needed to support regulatory submissions.
  • Contribute to continuous process improvement initiatives; promote ideas for optimization.

About You:
  • BS/MS in a STEM field with 1-2 years of relevant work experience from related industry
  • Familiarity with IACUC and Good Laboratory Practices to anticipate necessary study resources
  • Proficiency with Microsoft Word, Excel, Powerpoint and GraphPad Prism
  • Experience managing scientific projects in a highly matrixed organization; evidence of collaboration in multidisciplinary environment
  • Experience simultaneously managing multiple research projects, priorities, studies, and external contract research organizations (CROs).
  • Experience managing rodent and large animal (e.g., non-human primate) studies
  • Prior biotech or pharmaceutical industry experience.
  • Prior pharmacology and/or toxicology experience.
  • Familiarity with regulatory guidance (FDA, ICH, OECD, etc.)
  • Experience with regulated clinical/commercial development of gene therapy or cell therapy products.

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.