Associate Director, Early Development Lead

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 who is a strategic safety leader responsible for designing and implementing safety surveillance and risk management strategies for preclinical and early clinical assets. Apply scientific and medical judgement to analyse safety data, develop risk mitigation plans, and contribute to regulatory submissions. Be the safety representative on research and early development teams, ensuring understanding of regulatory, company, and stakeholder safety expectations.

• 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 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.

• PHD degree or medical degree ( Doctors) with exposure to basic research work
• Minimum 5 years in pharmaceutical/biotechnology industry in a safety or research role.
• At least 3 years working with early clinical development assets (Phase 1/2, including FIH studies).
• Subject matter expertise in toxicology, pharmacology, and manufacturing aspects relevant to safety.
• Previous experience in performing qualitative benefit-risk assessments.
• Strong communication skills with the ability to convey complex concepts, seek feedback, and tailor messages to audiences.
• 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
• Deep knowledge of PV systems, regulatory frameworks, and safety documentation (e.g., DSURs, RMPs, IBs)