Director, Clinical Operations Lead

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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.

Location Options: Maidenhead UK, King of Prussia PA US, Zurich CH.
Hybrid – 3 days a week in the office; fully remote not considered.

• Clinical Operations Strategy:
  Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality for the 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.
• 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 budgeting.
• End‑to‑End Clinical Study Management:
  Plan, manage, and execute the 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.
• Provide regular study status updates, including critical issues, to senior leadership and support the study team with stakeholder management and issue escalation.
• Support audits/inspections and resolution of findings.
• Contribute to the leadership of the Clinops function in change and continuous improvement initiatives, including development of new SOPs, guidelines, and participation in working groups.
• Functional leadership and mentorship of junior staff; act in advisory capacity to clinicians across therapeutic areas, ensuring cross‑functional process efficiencies and compliance.

Education

Minimum:
Bachelor’s degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. Other degrees and certifications considered if commensurate with related clinical research experience.

Experience

• Minimum 12 years of relevant clinical research (or related) experience within the pharmaceutical industry.
• Previous experience leading and managing a team of professional staff.
• Solid understanding of the drug development process, specifically each step within the clinical trial process.
• Experience overseeing large and/or complex global clinical trials.
• Robust budget forecasting and management experience.
• Thorough knowledge of ICH guidelines/GCP and applicability to all stages of clinical development.
• Demonstrated ability to lead teams, work in fast‑paced environments, and resolve conflicts in a matrix setting.
• Mentoring and coaching of others, developing reporting personnel to grow in complex clinical project management.
• Strong interpersonal, decision‑making, and communication skills, including written and oral communication.
• Innovative mindset, drive, energy, and enthusiasm to deliver program objectives.
• Skills for…