Your Role

The Director, Early Development Safety Lead provides expertise focusing on all aspects of safety in the evaluation of pre- and early clinical assets, contributing to the protection of patients and public health.

You will apply sound scientific and medical judgment in the analysis and interpretation of safety data from all relevant sources, including: literature, research, toxicology, pharmacology, data science, academia for signal detection and initiation of safety risk management activities.

This includes development of the safety specification, Pharmacovigilance (PV) planning and risk mitigation.

Your Responsibilities

• Provide strategic input into pre-clinical & early clinical development, regulatory and issue management activities and represents the position of GCSP in internal governance committees, in discussion with regulatory agencies if needed
• Safety Surveillance and Risk Management: Develop risk mitigation strategy for assets proceeding in early clinical development (e.g., FIH studies or phase 1 studies of established products in other indications) and ensure CSL Safety Governance endorsement of the proposed risk mitigation strategy
• Clinical Safety: Ensure that proposed risk mitigations for early clinical studies are reflected in relevant sections of clinical trial documents including protocols, investigator brochures, informed consent forms
• Contribute to analysis of aggregate safety data and ensure a thorough and consistent approach to the review of emerging safety data from pre-clinical and early clinical studies
• Serve as the safety representative in the research and early clinical development teams and be responsible for setting the safety strategy for the emerging projects
• Identify tools necessary to facilitate pre- and early-clinical safety assessment and implement necessary risk management initiatives
• Comply with legal requirements and company standards of PV (Pharmacovigilance)
• Engage and influence cross-functional stakeholders to ensure that safety is included in relevant discussions

• MD (Medical Doctor) degree, international MD equivalent or advanced life sciences degree
• Five (5) years pharmaceutical / biotechnology industry experience, preferably in a safety role
• Three (3) years' experience working with assets in early clinical development (phase 1 and phase 2), including FIH studies
• Experience analysing toxicology and pharmacology data and being able to further extrapolate it into the development of early risk mitigation strategies
• Understanding of the Product development process, the relevant scientific principles, and roles of contributing functions (e.g., clinical development, toxicology, clinical pharmacology epidemiology, biostats, regulatory affairs)
• Performing qualitative benefit-risk assessments, Signal and Risk Management
• Identifying safety signals from continuous review of toxicology and non-clinical/animal data
• Evaluating signals for causality; identifying, classifying, and determining the impact of risk and confounding factors; conducting follow-up investigations
• PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, ICSR mgmt.)