CSL Benefits Overview

Lead statistical strategy and execution for clinical development programs. Oversee study design, SAP authoring, data analysis, TFL/CDISC deliverables, CRO/vendor oversight, regulatory interactions, and interpretation of results to support submissions and program decisions.

Leads translational research and preclinical development for CSL Behring’s immunology portfolio. Designs in vitro and ex vivo studies, develops pharmacodynamic and biomarker strategies, supports toxicology and early clinical studies, and collaborates with pharmacology, clinical development, CRO, and internal teams. Responsibilities include preparing research plans, regulatory and clinical documents, supporting indication selection and due diligence, aligning projects with therapeutic-area strategy, and building external scientific networks.

Leads global regulatory affairs activities, securing permits, licenses, certificates, authorizations, and approvals for business operations and product distribution. Advises management on regulatory developments, manages regulatory plans and documentation, maintains regulatory systems, and represents the organization before government and industry authorities. Requires pharmaceutical regulatory experience, with biologics experience preferred.