Principal Scientist - Toxicology
$144,000–$180,000 year
On-siteMontréal, Quebec, Canada
Job Summary
Lead the planning, design, execution, and interpretation of nonclinical toxicology programs for IND, CTA, and BLA submissions, covering general, reproductive, and developmental toxicology studies. Serve as the primary scientific interface with CROs to ensure GLP-compliant delivery and author regulatory documents including INDs, CTAs, IBs, and BLAs. Represent the Nonclinical Safety function in cross-functional teams to inform candidate selection and risk assessment, while driving the evolution of integrated safety strategies across the therapeutic portfolio. Maintain scientific leadership by translating regulatory guidance and emerging methodologies into best practices for internal programs.
Required Qualifications
- 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
- PhD in Toxicology or a related field
- 8+ years of relevant industry experience supporting biologics development
- Ability to lead scientific discussions and influence decision-making within highly matrixed, cross-functional teams through clear, confident, and effective communication
- Excellent scientific writing skills, with experience authoring and reviewing toxicology reports and regulatory submission documents
- Strong organizational and prioritization skills, enabling effective management of multiple programs and timelines in a fast-paced environment
- Sound scientific judgment and critical problem-solving skills to assess complex datasets, identify risks, and propose strategic solutions
- Flexibility, resilience, and a proactive approach to change in a dynamic, evolving environment
Desired Qualifications
- Experience with oncology and/or ADC programs
- MSc degree and 12+ years of directly applicable experience
- DABT accreditation
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.