CSL
Principal Scientist, Clinical Assay Strategy X3
CSL, Waltham, Massachusetts, United States, 02254
Principal Scientist, Clinical Assay Strategy X3
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.
This hybrid position is located in our Waltham, MA office. You will report to the Director of Clinical Assay and work onsite three days a week.
Position Summary You will be part of a specialized non‑laboratory team and provide high‑level expertise in bioanalytical and biomarker assays to support nonclinical and clinical studies. The role will support external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs.
Responsibilities
Implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company’s overall goals and objectives.
Lead 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, and clinical submission readiness.
Provide timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post‑marketing requirements.
Direct the implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance.
Identify and proactively manage risk with externalization of critical bioassays.
Implement operational plans to ensure successful technical transfer of assays to external vendors with required compliance, concordance, quality, and within timelines.
Work with Clinical Bioanalytics and Biomarker leadership to execute robust insourcing/outsourcing strategy and optimize workflows to reduce turnaround times, assay transfers, budgets, and resource allocation.
Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarker function, ensuring best practices in experimental design, data analysis, and compliance with regulatory requirements.
Contribute to the preparation and review of regulatory submissions, responding to regulatory queries on bioanalytical and biomarker data.
Initiate and foster partnerships with cross‑functional CSL R&D teams, external vendors, industry experts, and collaborators to manage risk and ensure timely project progression.
Represent the organization at scientific conferences and industry meetings.
Drive innovation by adopting the latest advances in platforms, bioanalytical/biomarker formats, assay design, data analysis, automated workflows, and AI in regulated environments.
Qualifications
Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field.
Minimum of 5 years’ relevant industry experience and/or equivalent academic experience.
Track record of scientific achievement in relevant Life Sciences discipline.
Experience working in cross‑functional, multicultural, and international teams.
Expertise in compliant PK, ADA, biomarker, flow cytometric assay development, validation, and conduct to support clinical studies.
Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. Our benefits are designed to support the needs of our employees at every stage of their lives, including health care, financial protection, mental health resources, and charitable giving.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies for conditions across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas.
Inclusion and Belonging At CSL, inclusion and belonging are at the core of our mission and culture. We celebrate differences, foster curiosity and empathy, and build a diverse workforce that drives innovation and excellence.
Do Work That Matters Join us and help make a meaningful difference worldwide.
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This hybrid position is located in our Waltham, MA office. You will report to the Director of Clinical Assay and work onsite three days a week.
Position Summary You will be part of a specialized non‑laboratory team and provide high‑level expertise in bioanalytical and biomarker assays to support nonclinical and clinical studies. The role will support external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs.
Responsibilities
Implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company’s overall goals and objectives.
Lead 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, and clinical submission readiness.
Provide timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post‑marketing requirements.
Direct the implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance.
Identify and proactively manage risk with externalization of critical bioassays.
Implement operational plans to ensure successful technical transfer of assays to external vendors with required compliance, concordance, quality, and within timelines.
Work with Clinical Bioanalytics and Biomarker leadership to execute robust insourcing/outsourcing strategy and optimize workflows to reduce turnaround times, assay transfers, budgets, and resource allocation.
Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarker function, ensuring best practices in experimental design, data analysis, and compliance with regulatory requirements.
Contribute to the preparation and review of regulatory submissions, responding to regulatory queries on bioanalytical and biomarker data.
Initiate and foster partnerships with cross‑functional CSL R&D teams, external vendors, industry experts, and collaborators to manage risk and ensure timely project progression.
Represent the organization at scientific conferences and industry meetings.
Drive innovation by adopting the latest advances in platforms, bioanalytical/biomarker formats, assay design, data analysis, automated workflows, and AI in regulated environments.
Qualifications
Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field.
Minimum of 5 years’ relevant industry experience and/or equivalent academic experience.
Track record of scientific achievement in relevant Life Sciences discipline.
Experience working in cross‑functional, multicultural, and international teams.
Expertise in compliant PK, ADA, biomarker, flow cytometric assay development, validation, and conduct to support clinical studies.
Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. Our benefits are designed to support the needs of our employees at every stage of their lives, including health care, financial protection, mental health resources, and charitable giving.
About CSL Behring CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies for conditions across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas.
Inclusion and Belonging At CSL, inclusion and belonging are at the core of our mission and culture. We celebrate differences, foster curiosity and empathy, and build a diverse workforce that drives innovation and excellence.
Do Work That Matters Join us and help make a meaningful difference worldwide.
#J-18808-Ljbffr