Join to apply for the Director, Clinical Operations Lead role at CSL.
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.
Responsibilities
* 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.
Qualifications & Experience Requirements
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 navigating new or novel indications, study/program approaches, and unique challenges.
* Comprehensive knowledge of clinical development program tasks from protocol to clinical study report.
* Ability to plan and ensure execution and completion of clinical programs to the highest ethical and scientific standards.
* Proficient in reviewing and assessing clinical data and maintaining current medical/scientific/regulatory knowledge.
* Project management skills, including simultaneous management of multiple projects, with excellent planning, time management, and coordination skills.
* Problem‑solving and clear judgment in interactions with external parties, timelines, and complex clinical programs.
* Computer literacy in appropriate software.
We encourage you to make your well‑being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
#J-18808-Ljbffr