Associate Director, Early Development Lead, Medical Safety

Your Opportunity: CSL's R&D organisation is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.  We are looking for anAssociate Director, Early DevelopmentLead , Medical Safety who is astrategic safety leader responsible for the integrated interpretation of the totality of preclinical safety data,leveragingdeep scientificexpertiseand empirical evidence from diverse sources to assess and quantify uncertainty and potential patient safety risks. Translates complex safety insights into the design and execution of robust safety surveillance frameworks and proactive risk management and mitigation strategies for preclinical assets in advance of first-in-humanstudies. Servesas the safety representative on research and early development teams, ensuringcross-functionaland keystakeholdersalignmenton acceptabilityand expectedness of potential safety riskswhen weighed against unmet medical needs and therapeutic benefits,and risk mitigation strategies to be implemented. Reporting to the Senior Director, TA Head Vaccines & Head of Medical Safety Early Development Your Role: Develop and implement risk mitigation strategies for early development assets (e.g., FIH/Phase 1 studies), ensuring endorsement by CSL Safety Governance Review and interpret emerging safety data from preclinical and early clinical studies; contribute to aggregate safety data analysis and key safety documents (DSURs, risk management plans). Support the setup and evaluation of preclinical data packages,identifynew risks, anddetermineneeds for supplementary data. Respond promptly and concisely to regulatory agency safety requests Ensure risk mitigations are reflected in clinical trial documents (protocols, investigator brochures, informed consent forms) Provide guidance on safety issues andfacilitateinternal/external safety reviews (e.g., DMCs) Represent GSPV in cross-functional teams and chair safety management teams as needed. Your Experience: PHD degree,or medical degree(Doctors) with exposure to basic research work Minimum 5 years in pharmaceutical/biotechnology industry, preferably in a safety(MD)or research role(PhD) At least 3 years working with early clinical development assetsleading to FIHor Phase1-2studies Subject matterknowledgeinnon-clinicaltoxicology, pharmacology, and manufacturing aspects relevant to safety Ability to develop a risk management framework through identification of potential risks, likelihood/uncertainty, and impact assessment Ability to perform qualitativetherapeuticbenefit-riskassessments with guidance Strong communicationskills with the ability tosynthesizecomplex concepts, seek feedback, and tailor messagesfor effective communication Exhibit leadership skills like independent thinking, cross-functional influence, conflict management, and adaptability to diverse situations and cultures. Desirable Skills: Knowledge in safety signal identification, evaluation, escalation, and risk mitigation Knowledge of PV systems,familiarity withglobalregulatoryguidelinespertaining tonon-clinical safety and clinical safety Location: Melbourne CBD, also consider Zurich, Switzerland Hybrid Working. Closing date for Application Friday 30th January 2026 About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at . Our Benefits