Global Head of Clinical Operations

The Position:

The Vice President, Clinical Development Operations will have overall strategic and operational responsibility for the successful execution of the global portfolio of clinical programs across all therapeutic areas: Vaccines; Immunology & Transplant, Immunoglobulins; Hematology; Cardiovascular & Renal.

This position leads the organization to deliver optimized clinical trials, in collaboration with our chosen strategic partner CROs, supporting products that deliver lasting impact to patients’ lives and public health. The VP is responsible for creating and nurturing a strong culture, developing high performing teams and talent.

This leadership role drives growth with a focus on 6 key pillars:
• Delivering the development pipeline
• Ensuring operational excellence
• Innovating across clinical trial planning and execution
• Collaborating with strategic CRO Partners
• Optimizing healthcare worker and study participant interactions
• Operating with a strong business- and patient-focused mindset

The areas of responsibility include global functions involved with study delivery, including engaging the CRO on study level needs, oversight of CRO-delivered trial activities and oversight in the areas of feasibility, start-up, clinical data management, study management; site relationship management & monitoring; study document management; clinical compliance, and patient-focused clinical trial transformation.

Responsibilities:
Clinical Program Operational Leadership
• Provide overall operational leadership to all clinical programs, ensuring the R&D investment over >$400M in clinical studies is effectively managed
• Actively manage activities internally and externally to deliver industry top quartile cycle times in study execution, and in collaboration with Portfolio and Business Excellence, address challenges that are impeding predictable and reliable operational delivery
• Monitor and manage study level progress and challenges through leading operational governance. Represent Clinical Operations at internal governance meetings and leadership forums
• Manage departmental and program performance through key metrics and robust mitigation strategies
• Identify and deploy opportunities for Clinical teams to leverage cross-program synergies and to take advantage of new opportunities to drive innovation in delivery
• Continually assess operating procedures and take action to drive on-going quality improvement
• Strategically partner with key internal and external senior stakeholders to manage operational and departmental risks, as well as ensure study delivery objectives are achieved

Strategic Planning
• Create strategic vision aligned with R&D and CSL corporate strategic aspirations and create relevant roadmaps to achieve them
• Provide guidance and coaching to TA Clinical Operations Leads to ensure strategic operational input into all Clinical Development Plans
• Lead Clinical Development Operations teams to develop strategies to efficiently deliver according to company objectives
• Create vision for clinical trials of the future and develop approaches to connect with healthcare providers for an optimized patient and provider experience
• Partner with R&D Portfolio and Business Excellence to develop digital transformation vision and business cases for long term roadmap

Financial & Resource Management
• In partnership with Business Operations and key partners, develop and manage department budget as well as overall clinical trial delivery budgets to ensure efficient use of internal resources as well as accurate forecasting across the portfolio of studies
• Lead the prioritization of work and resources across all clinical programs
• Ensure all Clinical Programs are adequately resourced with both internal and external support
• Create and optimize a scalable resourcing strategy to support seamless delivery of clinical studies with a combination of internal and external resources

Regulatory Compliance
• Ensure all areas of accountability are compliant with ICH/GCP guidelines as well as other regulatory standards and requirements both internally at CSL and with our strategic CRO partners
• Ensure coordinated relationship with CQA to drive inspection readiness and overall quality of clinical studies

Lead People
• Develop culture that enables successful recruitment and retention of high-quality Clinical Development Operations staff
• Create a culture of high performing teams able to work effectively in a matrixed environment
• Create and encourage a culture of experimentation, innovation and applied learning
• Ensure effective utilization and performance management of staff
• Lead, coach, develop, and retain management team with an emphasis on developing capacity in strategic thinking, op