Principal Clinical Scientist

The Opportunity

Reporting to the Director, Clinical Scientist Lead, you will support the Hematology, Transplant, and Immunology Therapeutic Areas in a multifunctional, clinical project role. You will work closely with the Program Director and other Clinical Scientists in performing delegated tasks to support the clinical development program as dictated by therapeutic area/ project needs.

The Role

• Contribute to the scientific development of clinical programs and individual clinical studies according to the clinical development plan within the assigned therapeutic area.
• Provide scientific and clinical development input for the safe, efficient, execution of assigned programs, ensuring the highest quality and full compliance of all outputs.
• Author and contribute to the development of program and study level documents and training materials aligned with the scientific strategy (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings).
• Contribute to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents.
• Define and implement the medical monitoring and oversight strategy of individual clinical studies to ensure exceptional patient safety and data integrity, including ongoing review of blinded data.
• Manage the processes and liaisons required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, clinical events committee).
• Collaborate with internal and external cross-functional stakeholders to ensure translation of the clinical development strategy and clinical protocol into operational deliverables.
• Contribute to diverse working groups to support continuous process improvement.

Your skills and experience

• Bachelor’s degree, or equivalent, in a Science related field is required. An advanced degree (MS, PhD) in Science or Allied Health is preferred.
• 8+ years’ experience in the biotechnology or pharmaceutical industry (or where relevant, a biomedical research organization) or equivalent
• At least five years’ experience in clinical research
• In-depth knowledge in the drug development processes for pharmaceuticals (e.g. project management, CMC, non-clinical, clinical, Regulatory Affairs).

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.