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Associate Director/Director, Toxicology/Preclinical Safety

Boston, MA

About GentiBio

GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children’s Research Institute, Benayroya Research Institute, and MIGAL Gaililee Research Institute. GentiBio is focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio’s proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics.

GentiBio is seeking to build an organization with an exceptional company culture focused on empowerment, care for our team members, an appreciation for diversity and inclusion, and the development of our people. As such, we are looking for candidates who are not just great scientists but individuals who are looking to contribute to building and modeling an outstanding company culture – and having fun while doing so.

GentiBio is building corporate operations in both Boston and Seattle. We are looking for outstanding leaders and scientists to join our team in both of our locations for the right candidate this role can be remote. 

Job Summary 

GentiBio is seeking an experienced toxicology and preclinical safety expert to develop the toxicology and safety assessment platform for Tregs and other cellular therapies in the GentiBio pipeline. This individual will develop toxicology strategies to support IND for the first engineered Treg used to treat auto-immune disorders. The successful candidate will be required to identify the most appropriate preclinical toxicology studies and endpoints necessary to support regulatory filings. This individual will collaborate with the manufacturing team to ensure the on- and off-target editing plans are aligned and sufficiently address potential toxicological risks. 

Job Responsibilities 

  • Lead the design of toxicology studies and data interpretation  
  • Develop plans to evaluate on- and off-target editing 
  • Identify and manage relationship with CROs contracted to execute planned toxicology and safety studies 
  • Design, execute, and interpret complex preclinical studies serving multiple objectives (biodistribution, safety, toxicology, etc.) 

Qualifications and Education Requirements 

  • PhD or DVM with at least 7-10 years of experience in toxicology and safety assessment 
  • Experience working with cellular/gene therapies required 
  • Extensive experience authoring IND modules 
  • Deep understanding of integration site analysis 
  • Excellent knowledge of the regulatory guidance for cellular therapies 
  • Strong interpersonal skills and demonstrated leadership required
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