Hybrid Associate Director, Early Development Lead, Medical Safety

at CSL

• Job title: Associate Director, Early Development Lead, Medical Safety
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Melbourne, Australia

About the role

• Associate Director leading medical safety and risk strategies in early development at CSL Behring. Focused on patient safety and cross-functional collaboration in clinical trials.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities