With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Senior toxicologist will prepare toxicological risk assessments supporting all therapeutic areas by applying state-of-the-art methods.
Further, the incumbent will be responsible for the design, adequate budgeting and monitoring of non-clinical safety studies (including in-vitro methods) 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.
This role has global responsibilities, including participation in global teams. This role reports to the Director Toxicology.
- Prepare and review toxicological risk assessments supporting R&D projects, liaising closely with Global Clinical Safety & Pharmacovigilance (GCSP) and Global Medical Support Quality
- Develop, implement and execute a process for managing the compilation of toxicological risk assessments
- Develop immunotoxicology strategies and provide immunotoxicological expert support across research and development projects.
- Serve as function's representative across R&D projects across therapeutic areas
- Manage and coordinate internal and external toxicology studies (including in-vitro methods) as part of global teams.
- Take responsibility as preclinical project lead for selected research or development projects.
- Oversee and manage toxicology programs along clinical development up to marketing.
- Plan, monitor, analyze and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.
- Actively collaborate with global, cross-continental project teams.
- Support the preclinical evaluation of external assets and in-licensing opportunities
- Support improvement initiatives to enhance efficiency and quality of the group's deliverables.
- Actively establish and foster a high quality, global network with relevant experts internally and externally
- Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields
- Toxicology training, board certification preferred
- Training in immunotoxicology preferred
- Education in chemistry of advantage
- At least 5 years of work experience including at least 3 years as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting.
- Relevant experience in biopharmaceutical development.
- Additional experience in development of cell and gene therapy and monoclonal antibodies 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 in in-vitro toxicology welcome
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Experience in working in cross-functional, multicultural and international teams.
- Excellent communication and analytical skills. Experience in medical/regulatory writing preferable.
- Experience in analyzing and presenting research results to scientific and professional audiences.
- Strong planning and organizational skills.
- Ability to work successfully in a matrix organizational structure.
- Strong negotiation skills and ability to identify and engage internal and external expertise as needed.
- Good understanding of drug development process, strong knowledge of ICH/GLP
- Fluent in English, oral and written;
- German language skills of advantage
- Working across global time zones
- Office Environment
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms
- Occasional domestic and international travel required.