Director, Clinical Operations Lead

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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.

The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and / or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies) / program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines budget and quality standards and according to the TA strategies.

This role must be experienced in working in a matrix environment (internal and external partners) with cross-functional responsibilities associated with trial execution and overall therapeutic area clinical development planning. Strong communication and presentation skills are required.

• Clinical Operations Strategy :
  Design and implement operational strategies study management plans and supporting documentation to drive study efficiency and quality (most complex studies). Continuously assess and improve clinical operations processes. Provide early input in CDP and study outline.
• Project Management & CRO oversight :
  Lead cross-functional study teams coordinate with functional area representatives and ensure timely execution of all study-related activities. Responsible for vendor selection / management / oversight issue escalation and inspection readiness.
• Stakeholder Management & Team Leadership :
  Lead and coordinate cross-functional teams fostering collaboration among internal and external stakeholders (including vendors investigators and regulatory authorities). Act as the primary point of contact for all study-related matters build and maintain strong relationships mentor and support team members and represent the study team in communications with senior management. Act in an advisory capacity to other clinops colleagues and ensure knowledge sharing across therapeutic areas.
  
  Be the clinops voice at PST / TALT.
• Budget Forecasting and Performance Management :
  Forecast manage and report on study budgets and key performance metrics including study start-up enrollment and data collection timeliness / quality. Engage with key project stakeholders including GPLS TALT leads Finance POE. Drive accuracy and reliability in terms of budget.
• End-to-End Clinical Study Management :
  Plan manage and execute our most complex global clinical studies from protocol development through to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving. Oversee timelines budgets regulatory / GCP compliance feasibility country strategy enrollment plans and risk mitigation.
• Act as the primary point of contact both internally and externally (e.g. vendors) as applicable for anything study / program / asset related.
• Provide regular study status updates including critical issues to senior leadership as needed while providing support to the study team with stakeholder management and issue escalation. Portray strong and confident communication and presentation skills. Audiences will include those both internal and external partners.
• Support audits / inspections and resolutions of findings.
• Contribute to the leadership of the Clinops function in key areas of change and continuous improvement. May be asked to lead cross functional change initiatives. Support in the development of new SOPs guidelines etc and / or participate in working groups about new processes and change initiatives.
• Functional leadership and mentorship of junior staff required;
  Act in advisory capacity to other clinops colleagues within and across TAs.
• Acts as an integral resource for clinops members and ensures that cross-functional process efficiencies are identified and maximized in accordance…