Description
Summary:
Project Toxicology Role: The Principal Toxicologist will lead and manage nonclinical safety strategies across multiple drug development projects. This role serves as the primary toxicology representative on interdisciplinary project teams, will lead the Nonclinical Expert Team (NCET) and provides scientific leadership from early discovery through regulatory submission and market authorization. The role is responsible for the design, adequate budgeting, and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment
Regulatory Toxicology Role: The Principal Toxicologist will compile Toxicological Risk Assessments across multiple drug development projects supporting R&D, CMC and Quality and/or will compile nonclinical submission documents across all projects.
Main Responsibilities:
Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.
Act as Nonclinical Development representative in Research Project teams.
Design, oversee, and interpret nonclinical safety studies (GLP and non-GLP) to support regulatory submissions and drug development.
Develop and implement toxicology strategies aligned with clinical development plans.
Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities
Prepare and review regulatory nonclinical submission documents
Collaborate with internal stakeholders including pharmacology, PK, clinical, regulatory, and CMC teams.
Present integrated safety assessments to senior management and at project milestone reviews.
Compile toxicological risk assessments for impurities, extractables and leachables, excipients, and other components in line with ICH, EMA, and FDA guidelines
Stay current with evolving toxicology guidelines and risk assessment methodologies.
Qualifications and Experience Requirements:
PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field. Board Certification (ERT or DABT) or equivalent is a plus.
5-8 years of experience in pharmaceutical or biotech industry.
Proven track record in nonclinical safety assessment and regulatory submissions.
Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
Excellent communication, leadership, and cross-functional collaboration skills.
Experience with CSL’s disease therapeutic areas.
Experience across multiple therapeutic areas and modalities is highly desirable.
Our Benefits
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