Principal Toxicologist (f/m)

As Principal toxicologist, you will develop the toxicology strategy of assigned programs. You will manage the design, budgeting and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment followed by the interpretation, communication and reporting of non-clinical safety data generated and collaborate with global project teams and work with regulatory health authorities and external experts. You will contribute individually and oversee the activities of small, global team of functional experts.

The Role

RESPONSIBILITIES AND ACCOUNTABILITIES

• Develop toxicology strategies and provide toxicological expert support to research and development projects.
• Manage toxicology programs along clinical development up to marketing.
• Be the function's representative across activities in the area Biopharmaceuticals
• Plan, monitor and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.
• Prepare toxicological risk assessments to support drug development and manufacturing.
• collaborate with global, cross-continental project teams.
• Prepare non-clinical documents as part of regulatory submissions and interactions.
• Support the preclinical evaluation of external assets and in-licensing opportunities
• Maintain a high level of awareness of scientific developments and the competitive environment to assist on ongoing strategic re-evaluation of ongoing programs.
• establish and foster a high quality, global network with relevant experts internally and externally

SKILLS and EXPERIENCE

• Postgraduate degree (preferably MSc or PhD) .
• Toxicology training, board certification preferred
• At least 5 years of experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting.
• Relevant experience in Biopharmaceutical development (protein, monoclonal antibodies) and Immunotoxicology.
• Additional experience in development of gene therapies, RNA-based therapies and small molecules of advantage
• In-depth knowledge of relevant regulatory guidelines.
• scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology.
• Experience working in multicultural and international teams.

Our Benefits

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 leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.