Principal Scientist Toxicology

Description

As Principal Toxicologist, this role leads and manages nonclinical safety strategies across multiple drug development projects. The incumbent serves as the primary toxicology representative on interdisciplinary project teams, leads the Nonclinical Expert Team (NCET), and provides scientific leadership from early discovery through regulatory submission and marketing authorization. The role is responsible for the design, adequate budgeting, oversight, monitoring, interpretation, communication, and reporting of nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

Responsibilities and Accountabilities

·       Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.

·       Act as the Nonclinical Development representative on Research Project teams.

·       Design, adequately budget, oversee, monitor, interpret, communicate, and report nonclinical safety studies conducted internally and externally in GLP and non-GLP environments.

·       Develop and implement toxicology strategies aligned with clinical development plans from early discovery through regulatory submission and marketing authorization.

·       Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities.

·       Prepare toxicological risk assessments supporting drug development, manufacturing, and product quality.

·       Prepare and review nonclinical documents for regulatory submissions and interactions with health authorities.

·       Collaborate with internal stakeholders, including pharmacology, PK, clinical, regulatory, CMC, and Quality teams.

·       Present integrated safety assessments to senior management and at project milestone reviews.

• Maintain awareness of evolving toxicology guidelines, risk-assessment methodologies, scientific developments, and the competitive environment.

Education and Experience

Education

• PhD, DVM, MD, PharmD, or equivalent advanced degree in Toxicology, Pharmacology, Life Sciences, or a related field.
• Toxicology board certification (ERT, DABT, or equivalent) is preferred.

Experience

• At least 5 years of experience as a nonclinical toxicologist in the pharmaceutical, biotechnology, or CRO environment.
• Proven track record in nonclinical safety assessment, toxicology strategy, and regulatory submissions.
• Relevant experience in biopharmaceutical development, including proteins or monoclonal antibodies, and immunotoxicology.
• Additional experience with gene therapies, RNA-based therapies, or small molecules is advantageous.
• Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
• Scientific experience in one or more relevant therapeutic areas and across multiple modalities is highly desirable.

Competencies

·       Excellent scientific leadership, communication, analytical, and cross-functional collaboration skills.

·       Proven ability to work effectively both independently and within cross-functional, multicultural, and international teams.

·       Ability to develop scientifically sound toxicology strategies, manage risks, and communicate integrated safety assessments clearly.

·       Strong planning and organizational skills, with demonstrated ability to manage priorities and timelines.

·       Ability to work successfully in a matrix organization and engage internal and external expertise as needed.

·       Experience in scientific and regulatory writing and in presenting results to scientific, project, management, and regulatory audiences.

• Fluent in written and spoken English.

About CSL Behring

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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.