Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins X2

Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins X2 page is loaded## Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins X2locations:
Americas, US-MA, Waltham, CSL Behring time type:
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募集開始 - 今日job requisition :
R-263480

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.

You will be part of a specialized non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential.

The incumbent will have a broad and deep knowledge base in relation to development and validation of  PK, ADA and biomarker assays. This role requires high excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams and execute externalization of compliant bioanalytical and biomarker assays . The candidate will need to have a deep understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types and context of use.
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* Main Responsibilities:

** Leadership and Strategy  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.

Research and Development  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 technical transfer of assays to external vendors with required compliance, concordance, quality and within timelines to meet project requirements.

Project and Resource Management  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 turn around times, assay transfers, budgets, and resource allocation.

Scientific Oversight  Interpretation of moderate complexity data, ability to troubleshoot and define next steps across areas of expertise for often complex issues.  Recognized subject matter expert in job area  typically obtained through advanced education and work experience.  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 to support project needs.  

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…