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CSL · 1 day ago

Senior Director, Head of Global Case Management

Greater Philadelphia

Full-time

Hybrid

Director/Executive

15+ years exp

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. The Senior Director, Head of Global Case Management will be a strategic leader ensuring a lean and agile organization that delivers high standards of patient safety while maintaining compliance with global regulations.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Hiring Manager

Jamie O'Malley

Responsibilities

Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities

Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards

Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices

Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence

Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign

Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processes

Foster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability

Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages

Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency

Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations

Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations

Develop and establish an innovative vendor oversight and management model to drive ICSR excellence

Define and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance

Collaborate with vendors to implement quality improvement initiatives and address compliance challenges

Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards

Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals

Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved

Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization’s strategic vision

Establishment and maintenance of a high performing outsourced medical evaluation function

Directing the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL’s signal detection framework

Qualification

Vendor oversightPV technology solutionsTransformation project leadershipOrganizational redesignData privacy complianceInnovationBudget managementCollaborationCommunication

Required

Bachelor's Degree in a relevant scientific or technical field (e.g., MS, PhD, PharmD) preferred

15+ years in leading multi-year transformation projects, including outsourcing and organizational redesign within PV operations

Profound experience in vendor oversight and management applying innovative approaches to achieve case management excellence

Demonstrated expertise in implementing PV technology solutions, such as intake automation, safety databases, signal detection, literature screening, and risk management

Extensive experience in managing global teams and partners

Hands-on experience in vendor management, including negotiating contracts and building large offshore vendor models