Director, Clinical Operations Lead

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.

Accountable for the development of the operational strategy for clinical study(ies) and/or a clinical program( s ) and for 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 in accordance with the TA strategies.

The role requires experience 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 and 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 Clin Ops colleagues and ensure knowledge sharing across therapeutic areas.
  
  Be the Clin Ops 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 and 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 supporting the study team with stakeholder management and issue escalation. Portray strong and confident communication and presentation skills. Audiences will include both internal and external partners.
• Support audits/inspections and resolutions of findings.
• Contribute to the leadership of the Clin Ops function in key areas of change and continuous improvement. May lead cross‑functional change initiatives. Support 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 Clin Ops colleagues within and across TAs.
• Act as an integral resource for Clin Ops members and ensure that cross‑functional process efficiencies are identified and maximized in accordance with project goals and that compliance…