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Director, Regulatory Genomics
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Full-time
- Within this leadership role, you will support the in vivo and cell therapy development programs in genotoxicity strategy and implementation.
- Serve as SME for genotoxicity assessment in support of in vivo and cell therapy development program advancement to the clinic
- Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs
- Partner with computational biology and software engineering on effective approaches for data capture, structuring, analysis and delivery
- 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
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