As Principal toxicologist, this role is responsible for developing the toxicology strategy of assigned programs. The incumbent will be 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 followed by the interpretation, communication and reporting of non-clinical safety data generated and liaise closely with global cross-functional project teams and interact with regulatory health authorities and external experts. The incumbent will contribute individually as well as oversee the activities of small, global team of functional experts.
RESPONSIBILITIES AND ACCOUNTABILITIES
Develop toxicology strategies and provide toxicological expert support to research and development projects.
Oversee and manage toxicology programs along clinical development up to marketing.
Serve as function's representative across activities in the area Biopharmaceuticals
Plan, monitor, analyze 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.
Actively collaborate with global, cross-continental project teams.
Prepare and review 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.
Actively establish and foster a high quality, global network with relevant experts internally and externally
Postgraduate degree (preferably MSc or PhD) and / or extensive experience in relevant discipline.
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/or small molecules of advantage
In depth knowledge of relevant regulatory guidelines.
Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology.
Experience working in cross-functional, multicultural and international teams.
Excellent communication skills (English language).
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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About CSL Behring
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 .
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