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 an Associate Director, Early Development Lead , Medical Safety who is a strategic safety leader responsible for the integrated interpretation of the totality of preclinical safety data, leveraging deep scientific expertise and 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-human studies. Serves as the safety representative on research and early development teams, ensuring cross-functional and key stakeholders alignment on acceptability and expectedness of potential safety risks when 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, identify new risks, and determine needs 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 and facilitate internal/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 assets leading to FIH or Phase 1-2 studies Subject matter knowledge in non-clinical toxicology, 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 qualitative therapeutic benefit-risk assessments with guidance Strong communication skills with the ability to synthesize complex concepts, seek feedback, and tailor messages for 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 with global regulatory guidelines pertaining to non-clinical safety and clinical safety