Director, Medical Evaluation & Case Processing Oversight

CSL's R&D organization 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.

Requirements

• Oversight of Case Management Processes activities
• Oversight of Medical Evaluator role which completes medical review of the following ICSRs:
• All serious cases from all sources
• Non-serious cases from company-sponsored clinical study, if required
• Legal ICSRs (serious and non-serious)
• Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)
• Drive department-wide planning: resource, budget, and org. strategy
• Own case management dashboards and governance scorecards
• Prepare for internal and external inspections including coordination of creation of presentations
• Lead transformation initiatives (e.g., vendor transitions, digital tools)
• Monitor regulatory trends and represent PV case management in global initiatives
• Coordinate departmental leadership meetings and communication
• Pilot innovations (e.g., RPA, AI triage, tech integration)
• Align with Clinical, QA, Regulatory, and Safety Science functions
• Coordinate creation and update of SOPs
• Retain product and process knowledge

Benefits

• 401k Matching
• Generous Paid Time Off
• Retirement Plan
• Tuition Reimbursement