CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Position Description Summary:
Project Toxicology Role: The Senior Toxicologist is responsible for monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment.
Regulatory Toxicology Role: The Senior Toxicologist will support Toxicological Risk Assessments across multiple drug development projects supporting R&D, CMC and Quality and/or will support nonclinical submission documents across all projects.
Main Responsibilities:
Design, oversee, and interpret nonclinical safety studies (GLP and non-GLP) to support regulatory submissions and drug development.
Proactively identify 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.
Support 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.
3-5 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, and cross-functional collaboration skills.
Experience with CSL’s disease therapeutic areas.
Experience across multiple therapeutic areas and modalities is highly desirable.
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.