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We are looking for an experienced, strategically minded Principal Scientist to join our expanding Non-Clinical Safety team based in Vancouver, Canada. You will be responsible for designing, planning, monitoring, and reporting of non-GLP and GLP toxicology studies and provide nonclinical safety support for early to late stage programs.
Job Responsibility
Leading the planning, design, execution and interpretation of nonclinical toxicology programs in support of IND, CTA and BLA submissions, including general toxicity and reproductive and developmental toxicology studies
serving as the primary scientific interface with contract research organizations (CROs)
representing the Nonclinical Safety function as a core member of cross-functional discovery and development program teams
providing critical scientific assessment of toxicology data and communicating clear, actionable risk-benefit evaluations and recommendations
authoring and reviewing nonclinical safety sections of regulatory documents (INDs, CTAs, IBs, and BLAs)
driving the development and evolution of integrated nonclinical safety strategies across AbCellera’s therapeutic portfolio
maintaining scientific leadership by staying current with advances in toxicology science
Requirements
PhD in Toxicology or a related field, with 8+ years of relevant industry experience supporting biologics development
MSc degree and 12+ years of directly applicable experience will also be considered
deep expertise in GLP-compliant nonclinical toxicology
hands-on experience with US FDA 21 CFR Part 58
strong working knowledge of FDA, ICH, and EMA nonclinical regulatory guidance
proven track record of designing, overseeing, and interpreting non-GLP and GLP toxicology studies in support of discovery and development programs
ability to lead scientific discussions and influence decision-making within highly matrixed, cross-functional teams
excellent scientific writing skills
strong organizational and prioritization skills
sound scientific judgment and critical problem-solving skills
flexibility, resilience, and a proactive approach to change
DABT accreditation (highly desirable, but not required)
experience with oncology and/or ADC programs is highly desirable
Nice to have
DABT accreditation
experience with oncology and/or ADC programs
What we offer
Equity
annual bonus dependent on team and company performance