Director, Genotoxicity Regulatory Lead

4 weeks ago

Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time
Transform Lives with Intellia Therapeutics, Inc.

We're a pioneering company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to positively impact the lives of people worldwide.

About the Role

We're seeking a highly skilled Director, Regulatory Genomics to support the advancement of genome editing products into the clinic. As a key member of our team, you'll play a crucial role in developing and implementing genotoxicity strategies for our in vivo and cell therapy development programs.

Key Responsibilities:
  • Develop and implement genotoxicity assessment strategies for in vivo and cell therapy development programs.
  • Collaborate with cross-functional teams to develop overall genotoxicity assessment strategies and defend recommendations to internal governance committees.
  • Partner with toxicology to provide guidance on genetic safety assessment for gene editing approaches.
  • Work closely with Genomic Innovation to align on genotox testing strategies for research programs headed to development candidate nomination.
  • Stay up-to-date on regulatory requirements for genome editing therapies and assess new technologies.
  • Collaborate with NGS production, Quality, and PreClinical Genotox to ensure compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs.
  • Partner with computational biology and software engineering to develop effective approaches for data capture, structuring, analysis, and delivery.
  • Support regulatory filings and interact with Health Authorities, both in writing and verbally.
  • Serve as an external SME for genotoxicity assessment, presenting at conferences, interacting with pre-competitive consortia, and supporting and writing manuscripts focused on genotoxicity methods and justification.
About You

We're looking for a highly experienced professional with a PhD and at least 10 years of directly related industry experience. You should have expertise in regulatory writing and strategy, as well as health authority interactions, with a focus on genomics and genotoxicity evaluation. Experience in supporting gene editing therapies into the clinic, with a focus on genotoxicity, is required. Additionally, experience with toxicology, NGS, sequencing methodologies, molecular biology, and gene editing approaches is preferred.

Meet Your Future Team

You'll be working closely with a talented team of experts in computational biology, toxicology, genomics innovation, and preclinical genotox to support the development of genome editing-based therapeutics into the clinic. We're 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'll report directly to the Vice President, Genomic Operations, who fosters a culture of teamwork, respect, inclusion, collaboration, and communication, ensuring that each team member strives to reach their professional and personal potential.

We're an equal opportunity employer and are committed to diversity, equity, and inclusion in the workplace. We welcome applications from qualified candidates and are happy to provide reasonable accommodations for individuals with disabilities.

Please note that all Intellia employees are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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