🌍 Strategically Safeguard Tomorrow’s Therapies Today
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 to assess and quantify patient safety risks. You will translate complex safety insights into robust safety surveillance frameworks and proactive risk management strategies for preclinical assets, ensuring alignment across research and early development teams.
Reporting to the Senior Director, TA Head Vaccines & Head of Medical Safety Early Development
đź“Ť Location:Â Melbourne CBD or Zurich, Switzerland |Â Hybrid Working
đź“‹ 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 Global Safety and Pharmacovigilance (GSPV) in cross-functional teams and chair safety management teams as needed.
👤 Your Experience:
- PhD degree or medical degree (MD)Â with exposure to basic research work.
- Minimum 5 years in pharmaceutical/biotechnology industry, preferably in a safety (MD) or research (PhD) role.
- 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, 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 and tailor messages for diverse stakeholders.
- Leadership skills including independent thinking, cross-functional influence, conflict management, and adaptability.
🌟 Desirable Skills:
- Knowledge in safety signal identification, evaluation, escalation, and risk mitigation.
- Knowledge of PV systems and global regulatory guidelines pertaining to non-clinical and clinical safety.
đź’Ľ About CSL Behring:
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop and deliver innovative therapies using advanced platforms in plasma fractionation, recombinant protein technology, and cell and gene therapy. Operating in over 100 countries, we are committed to fostering a diverse, inclusive workforce where every voice fuels innovation.
đź“… Closing date for Application: Friday 30th January 2026
🚀 Ready to Shape the Safety Profile of Breakthrough Therapies?
👉 Apply Now for the Associate Director, Medical Safety Early Development Role.
CSL is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
