Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins

Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins

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.

Could you be our next AD of Clinical Assay? The job is in our Waltham, MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay.

• Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company’s overall goals and objectives, supporting clinical programs with moderate complexity.
• Within a matrix environment provide leadership and mentor scientists within and across functional groups, fostering innovation and excellence.
• Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality, regulatory expectations, clinic/submission readiness and associated risks.
• Ensure the timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post‑marketing requirements.
• Direct the strategy and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance.
• Identify and proactively manage risk with externalization of critical bioassays.
• Establish operational plans to ensure the success of technical transfer of assays to external vendors with required compliance, concordance, quality and within timelines to meet project requirements.
• Work with Clinical Bioanalytics and Biomarker leadership team to execute robust in sourcing/outsourcing strategy, ensuring strategic decisions and effective utilization of available resources.
• Support the selection of vendors through in‑depth technical, strategic and scientific review; contribute to governance meetings, escalation of issues and tracking of KPIs.
• Optimize workflows to ensure optimal turnaround times, assay transfers, budgets, and resource allocation.
• Interpret moderate‑complexity data, troubleshoot and define next steps across areas of expertise for often complex issues.
• Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarkers function; ensure best practices in experimental design, data analysis, and compliance with regulatory requirements.
• Contribute to the preparation and review of regulatory submissions, providing expert input on bioanalytical and biomarker data responding to regulatory queries.
• Communicate scientific results clearly and concisely to appropriate audiences.
• Initiate and foster partnerships with cross‑functional CSL R&D teams, external vendors, industry experts, and collaborators to ensure timely project progression and risk management.
• Represent the organization at scientific conferences and industry meetings.
• Drive innovation by using up‑to‑date latest advances in platforms, bioanalytical/biomarker formats, assay design and data analysis, automated workflows and use of AI in regulated environments.
• Stay updated on advancements throughout the field to support current and emerging modalities.

• Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field (Hematology/CVR/Transplant/Immunology).
• 8+ years relevant industry experience and/or equivalent experience in a relevant academic environment.
• Strong and proven scientific background in relevant Life Sciences discipline.
• Demonstrated ability in managing highly effective teams that are cross‑functional, multicultural and international.
• Deep understanding of relevant regulatory guidance and industry best practices.
• Excellent analytical skills, ability to address complex problems through investigation and analysis.

For more information on CSL benefits visit How CSL Supports Your Well‑being.

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 is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit