Associate Director, Early Development Lead

CSL Limited • Full-time • Melbourne, Victoria, Australia • 1w ago

🔬 Lead Safety Innovation in Early-Stage Drug Development

Join CSL's dynamic R&D organization as an Associate Director, Early Development Lead and play a pivotal role in shaping the safety profile of our most promising early-stage assets. In this strategic leadership position, you'll leverage your scientific expertise to design and implement safety surveillance strategies that accelerate innovation while ensuring patient safety from first-in-human studies through early clinical development.

🎯 Your Impact: Key Responsibilities

Strategic Safety Leadership

Design and implement safety surveillance and risk management strategies for preclinical and early clinical assets
Serve as safety representative on research and early development teams
Ensure understanding of regulatory, company, and stakeholder safety expectations
Chair safety management teams and provide expert safety guidance

Risk Management & Analysis

Develop risk mitigation strategies for early development assets (FIH/Phase 1 studies)
Review and interpret emerging safety data from preclinical and early clinical studies
Perform qualitative benefit-risk assessments
Support setup and evaluation of preclinical data packages

Regulatory Excellence & Documentation

Contribute to aggregate safety data analysis and key documents (DSURs, RMPs)
Ensure risk mitigations are reflected in clinical trial documents (protocols, IBs, ICFs)
Respond promptly to regulatory agency safety requests
Facilitate internal/external safety reviews (e.g., DMCs)

Cross-Functional Collaboration

Represent Global Safety & Pharmacovigilance (GSPV) in cross-functional teams
Exhibit leadership through independent thinking and cross-functional influence
Manage conflicts and adapt to diverse situations and cultures
Communicate complex safety concepts effectively to varied audiences

⭐ Your Profile: Qualifications & Experience

Essential Requirements

PhD or Medical degree with exposure to basic research work
Minimum 5 years in pharmaceutical/biotechnology industry in safety or research role
At least 3 years working with early clinical development assets (Phase 1/2, including FIH)
Subject matter expertise in toxicology, pharmacology, and manufacturing aspects
Experience performing qualitative benefit-risk assessments

Technical Expertise

Knowledge in safety signal identification, evaluation, escalation, and risk mitigation
Understanding of PV systems and regulatory frameworks
Experience with safety documentation (DSURs, RMPs, IBs)
Strong analytical and interpretation skills for emerging safety data

Leadership Competencies

Excellent communication and stakeholder management skills
Ability to convey complex concepts and tailor messages to diverse audiences
Cross-functional influence and conflict management capabilities
Adaptability to diverse situations and global cultures
Strategic thinking and independent decision-making

💫 Why Join CSL R&D?

Impactful Innovation

Accelerate innovation in dynamic biotech ecosystems
Contribute to therapies that make meaningful differences worldwide
Work within a project-led, collaborative R&D structure
Join a future-ready team committed to patient impact

Leadership Opportunity

Strategic role shaping early development safety strategies
Direct influence on CSL Safety Governance decisions
Global visibility and cross-functional leadership
Opportunity to build and mentor within safety organization

Professional Environment

Agile, collaborative work culture
Focus on continuous learning and development
Inclusive environment that values diverse perspectives
Global biotechnology leader with life-saving portfolio

✨ Ready to Shape the Future of Drug Safety?

If you're an experienced safety professional with early development expertise and strategic leadership capabilities, we encourage you to apply. Join CSL in our mission to accelerate innovation while maintaining the highest standards of patient safety.