Principal Toxicologist
Core
Lead nonclinical development programs and ensure global regulatory compliance for nonclinical safety to enable therapeutic asset progression.
Role type
Principal Toxicologist (Senior IC)
Builds
Nonclinical safety programs and regulatory submissions for drug development
Domain
Pharmaceutical industry, Drug Safety, Pharmacometrics
Required skills
nonclinical safety assessment study design, regulatory risk assessment, CRO oversight, global regulatory guidelines knowledge, scientific mentoring, cross-functional collaboration
Preferred skills
experience with monoclonal antibodies, oligonucleotides, gene therapies, Ophthalmology, Oncology, Infectious Diseases programs
Technologies
GLP regulations, ICH guidelines, FDA guidelines, EMEA guidelines
Responsibilities
Develop regulatory risk assessment strategies and contribute to program planning and budgeting; Provide scientific oversight of CRO activities including study design, conduct, monitoring, and data interpretation; Author and review nonclinical safety content for global regulatory submissions; Communicate nonclinical safety data and strategies to internal and external stakeholders; Mentor junior scientists to promote scientific excellence; Maintain currency with global non-clinical safety guidelines and scientific developments
Seniority
Principal, hands-on IC with mentorship