Associate Director, Clinical Operations Lead

Associate 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.

The Associate 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). 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. This role typically manages one or more studies / or products, often the more complex in size and scope with minimal oversight and may take on additional responsibilities as defined by the Senior Director Clinops Program Lead.

Main Responsibilities :

• Clinical Operations Strategy : Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality (more 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.
• End-to-End Clinical Study Management : Plan, manage, and execute more 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 related.
• Maintain up to date knowledge of the therapeutic area / product candidate(s), clinical practice, competitors, and regulatory considerations.
• Support audits / inspections and resolutions of findings.
• Support in the development of new SOPs, guidelines etc and / or participate in working groups about new processes.
• Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs.
• When accountable to a set of studies and / or program(s) provides oversight and direction, ensuring appropriate delegation and delivery, inter-program efficiencies and applied learnings.

Qualifications and Experience Requirements :

Competencies :

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and / or diplomas in the original language. Please include all these in one document together with the CV.

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 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.

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status or other classification protected by applicable US federal, state or local law.