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Director, Genotoxicity Regulatory Lead
1 month ago
About the Role
We are 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 will play a critical role in developing and implementing genotoxicity strategies for our in vivo and cell therapy development programs.
Key Responsibilities
As a Director, Regulatory Genomics, you will be responsible for:
- Developing and implementing genotoxicity strategies for our in vivo and cell therapy development programs
- Collaborating with cross-functional teams to develop overall genotoxicity assessment strategies and defend recommendations to internal governance committees
- Partnering with toxicology to develop genetic safety assessment strategies for gene editing approaches
- Aligning with Genomic Innovation on genotox testing strategies for research programs headed to development candidate nomination
- Staying current on regulatory requirements for genome editing therapies and assessing new technologies
- Working closely with NGS production, Quality, and PreClinical Genotox to ensure compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs
- Partnering with computational biology and software engineering to develop effective approaches for data capture, structuring, analysis, and delivery
- Supporting regulatory filings and interacting with Health Authorities, both in writing and verbally
- Serving as an external SME for genotoxicity assessment for CRISPR-based products
We are looking for a highly experienced professional with a strong background in regulatory writing and strategy, as well as health authority interactions. You should have a PhD with 10 years of directly related industry experience and experience in supporting gene editing therapies into the clinic with a focus on genotoxicity. Additionally, experience with toxicology, NGS, sequencing methodologies, molecular biology, and gene editing approaches is preferred.
Meet Your Future Team
You will be working closely with a talented team of professionals who are passionate about developing innovative solutions for genome editing-based therapeutics. We are committed to 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.
