Gene Editing Off-Target Safety Lead; Lilly Genetic Therapies

Role Summary

Gene Editing Off-Target Safety Lead at Lilly Genetic Therapies. Join the rapidly expanding Gene Therapy team to invent, characterize, and advance novel genome editing reagents for clinical applications. The role focuses on developing safety characterization strategies for gene editing, leading a cross-disciplinary team, and delivering results to stakeholders including executive leadership.

Responsibilities

• Develop and execute strategic vision for gene editing safety characterization for multiple programs and serve as subject matter expert on gene editing safety for internal and external stakeholders.
• Establish clear data delivery timelines and quality standards for off-target characterization supporting regulatory submissions.
• Oversee implementation and optimization of IND enabling off-target quantification methods across multiple programs (GUIDE-Seq, UdiTaS, SITE-Seq, ITR-Seq, ONE-seq, etc.).
• Lead and mentor the Off-target Team and work with a cross-functional team spanning translational gene editing, off-target biology, NGS technologies, and laboratory automation.
• Develop and execute strategic vision for gene editing safety characterization workflows and establish high-throughput automation capabilities.
• Drive R&D initiatives to incorporate novel assays and emerging technologies into the gene editing pipeline.
• Deliver clear communication of technical capabilities, timelines, and results to diverse stakeholders and executive leadership.
• Support business development activities and external partnerships as needed.
• Champion continuous improvement, operational excellence and documentation practices.

Qualifications

• PhD in biology, molecular biology, genetics, bioinformatics, bioengineering, or closely related scientific field with 5+ years of experience, OR Masters in scientific field with 12+ years of relevant industry experience.
• Demonstrated experience leading technical teams and managing complex gene editing programs to advanced development milestones including regulatory filings.
• Mastery of gene editing technologies and safety assessment methodologies and de-risking strategies.
• Molecular biology mastery of NGS library preparation, qPCR, DNA & RNA extraction, and related technologies.
• Strong background in NGS technologies, including quantification, sequencing, and data QC.
• Track record of mentoring and developing scientific talent.
• Experience with automation is a plus.

Skills

• Gene editing technologies and safety assessment methodologies
• NGS library preparation, qPCR, DNA/RNA extraction
• Data QC and interpretation of sequencing results
• Team leadership and cross-functional collaboration
• Regulatory submission support and communication to stakeholders
• Automation and high-throughput workflow development

Education

• PhD or Master's degree in relevant field as specified in qualifications.

Additional Requirements

• This role may require up to 10-15% travel for conferences or training and will include mentoring/j training of junior scientists.
• Location: Lilly Seaport Innovation Center, 15 Necco St, Boston, MA 02210.