Senior Scientist, Toxicology

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.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.