Casebia Therapeutics

Job Title: Associate Director, Toxicology

Job Number: 21877

Location: Cambridge, MA

Job Description

Casebia Therapeutics is seeking an exceptional, innovative and highly motivated Toxicologist to apply their experience towards the advancement of impactful therapies across multiple therapeutic indications. All therapeutic areas will leverage Casebia’s technology in CRISPR genome editing, cell therapy, and advanced delivery modalities such as lipid nanoparticles and adeno-associated viruses.
This person will influence the emerging safety strategy for early discovery programs and contribute to the advancement of molecules from lead optimization and candidate selection into clinical development. As part of the team of scientists at Casebia Therapeutics, the successful candidate will have responsibility for predicting pharmacologically mediated toxicity, the design of safety studies to address them, the design, monitoring and conduct of IND-enabling studies, cross functional data interpretation and communication, as well as input on the strategy for assessing toxicology across an expanding portfolio. We are seeking motivated individuals to join a fast-paced and highly collaborative team environment who seek to play a pivotal role at each stage of preclinical and early clinical development.

Responsibilities

  • Provide expert support and guidance on safety assessments to the project teams spanning therapeutic areas and modalities including adeno-associated viruses, lipid nanoparticles and cell therapy
  • Conduct safety assessments to pharmacologically-mediated toxicity and design studies to investigate their relevance
  • Oversee preclinical toxicology studies at multiple external Contract Research Organizations (CRO). Initiate appropriate processes for contract implementation, protocol development, and timeline optimization for toxicology studies
  • Review and edit toxicology protocols and reports which also includes responsibility for bioanalytical, toxicokinetic and pathology contributor reports
  • Monitor toxicology studies for appropriate conduct, accuracy and timely execution (requires periodic travel); audit raw data for accuracy, review draft reports and finalize them as submission-ready documents for regulatory authorities
  • Proactively respond to study issues and come up with suggested resolutions
  • Review and/or author toxicology sections of various regulatory documents (e.g., pre-IND briefing documents, INDs, IBs etc.) and ensure their regulatory compliance
  • Excellent verbal and written communication and interpersonal skills to work within a project team setting, across functions, and with external collaborators.
  • Ability to independently solve problems and think creatively as part of a fast-paced research team

Required Skills

  • PhD in toxicology or related field or DVM with 8+ of relevant industry experience
  • Prior experience in lipid nanoparticles, cellular and gene therapies, or biologics strongly preferred
  • Extensive experience interfacing with, and providing scientific guidance to, CRO partners and proven ability to work efficiently in a hybrid model
  • Demonstrated expertise and track record of success in advancing discovery programs from target validation, through lead optimization, candidate selection and clinical development
  • Previous experience writing and/or editing sections 2.6.2 and 2.6.6 of an IND regulatory submission
  • Ability to influence in vitro/in vivo toxicology strategy and think critically and creatively as part of a fast-paced research team
  • Excellent verbal and written communication and interpersonal skills for participating across functional groups and externally
  • Demonstrated commitment to quality, attention to detail, and team player mentality
  • Must thrive in a fast-paced innovative, collaborative environment while remaining flexible, proactive, resourceful and efficient
  • Demonstrated ability to focus on the goal with a strong ability to analyze complex issues and drive to timely, thoughtful and realistic solutions and recommendations
  • Willingness to travel to monitor studies at CRO (approximately 10-20% time)
  • Ability to independently solve problems and think creatively as part of a fast-paced research team

 

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