Associate Director, In Vivo Pharmacologist

Location
Cambridge, MA, United States
Posted
Mar 13, 2021
Ref
R18
Hotbed
Genetown
Required Education
Other
Position Type
Full time

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:

Summary:

Intellia Therapeutics is seeking to support an expanding development pipeline with scientists to characterize the pharmacology and biodistribution of their innovative products. We are currently seeking an Associate Director/Director to serve as Pharmacology 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-derived cell therapy and gene editing products.

Responsibilities:

 

  • Contributes to the overall nonclinical development strategy for candidate therapeutic programs, throughout the drug development lifecycle
  • Highly effective interacting with other functional area experts in a program 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, interpretation, and reporting of definitive, FIH-enabling pharmacology and biodistribution studies
  • Reviews study designs and ensures interdependencies (e.g., Research, Bioanalytical, TechOps, Pathology, Quality) are aligned with emphasis on appropriate and efficient pharmacological and biodistribution evaluations
  • Serve as study monitor; prepared to support the execution of each study
  • Contributes investigative insight to confirm proof-of-mechanism, proof-of-therapeutic concept and prioritize experimental options to guide effective dosing approaches
  • Represents Intellia on partnered programs and at external venues such as scientific meetings
  • Succinctly and effectively communicates interpretation of nonclinical studies for regulatory submissions, including components for IBs and clinical protocols
  • Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
  • May be responsible for supervision of internal scientific staff or contracted staff (as needed)

 


Minimum Qualifications:

 

 

  • PhD or DVM with 6+ years of life sciences or industry experience, with at least 3 years of managing others in a matrixed environment. OR BS/MS with 10+ and 14+ years of experience respectively.
  • Experience managing multiple drug development programs and priorities, studies, external CRO management
  • Solid understanding of molecular biology, genetics and immunology

 


Preferred Qualifications:

 

 

  • Familiarity with ICH-guided, GLP-compliant nonclinical study design and conduct
  • Expertise in one or more immunology, immunogenicity, T cell biology, CAR-T, TCR-T
  • Experience with viral (e.g., AAV) and/or non-viral (e.g., lipid nanoparticle) delivery of nucleic acid therapies
  • Experience designing definitive studies using large animal (e.g., non-human primate) and/or adoptive cell transfer model systems (e.g., xenograft tumor models)
  • 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; recent experience contributing to IND/CTA filing for cell/gene therapy product.
  • Experience in oncology and/or rare disease therapeutic areas.

 


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.