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 Safetywho 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
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.
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.
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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
