AbCellera
Biotechnology
PrincipalScientistToxicology
“Principal Scientist - Toxicology at AbCellera. Skills: Toxicology, Nonclinical safety, Regulatory submissions. Design toxicology studies. Plan toxicology studies”
What You'll Achieve.
Deliver breakthrough medicines; High-quality GLP-compliant delivery
Industry & Context.
Critical problem-solving; Strategic solutions
What They're Looking For.
Must Have
PhD in Toxicology or related field, 8+ years industry experience (biologics), MSc degree and 12+ years experience, Deep expertise in GLP toxicology, Hands-on experience with US FDA 21 CFR Part 58, Working knowledge of FDA, ICH, EMA guidance, Track record designing toxicology studies, Ability to lead scientific discussions, Excellent scientific writing skills, Organizational and prioritization skills, Sound scientific judgment, Critical problem-solving skills, Flexibility and resilience
Nice to Have
Experience with oncology programs, Experience with ADC programs, DABT accreditation
What You'll Do.
Design toxicology studies
Plan toxicology studies
Monitor toxicology studies
Report toxicology studies
Provide nonclinical safety support
Lead planning of toxicology programs
Lead design of toxicology programs
Lead execution of toxicology programs
Lead interpretation of toxicology programs
Serve as scientific interface with CROs
Provide strategic oversight during protocol development
Provide strategic oversight during study conduct
Provide strategic oversight during data interpretation
Provide strategic oversight during report finalization
Represent Nonclinical Safety function
Contribute toxicology expertise
Inform candidate selection
Inform risk assessment
Inform program advancement
Provide scientific assessment of toxicology data
Communicate risk-benefit evaluations
Communicate recommendations
Author nonclinical safety sections
Review nonclinical safety sections
Contribute as subject matter expert
Drive development of safety strategies
Drive evolution of safety strategies
Maintain scientific leadership
Stay current with toxicology science
Translate insights into best practices
How You'll Work.
Team & Collaboration
Cross-functional program teams; Cross-functional teams; Senior leadership communication
Communication Scope
Scientific communication; Clear communication; Confident communication; Effective communication; Scientific writing; Regulatory document authoring; Regulatory document review; Global regulatory interactions; Health authority responses
Process & Methodology
Program management, Timeline management
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