CSL
Overview
CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. Join our agile team at the Waltham, MA office as the Associate Director (AD) of Clinical Assay. This is a hybrid role, onsite three days per week, reporting to the Director of Clinical Assay.
Position Description Summary You will provide high‑level expertise and leadership in bioanalytical and biomarker assays, supporting non‑clinical and clinical studies. Lead the external tactical execution of assays to deliver innovative data sets that meet business needs. Your deep knowledge of assay design, regulatory standards, and industry best practices will guide validation of PK, ADA and biomarker assays. Excellent communication and influencing skills are essential for collaborating with internal stakeholders and external vendors.
Main Responsibilities
Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis aligned with company goals.
Lead, mentor and support scientists across functional groups in a matrix environment.
Participate in external due diligence and advise on assay quality, regulatory expectations and clinical/submission readiness.
Ensure timely support for project progression from non‑clinical development through all phases of clinical development, including submissions and post‑marketing requirements.
Direct the strategy and implementation of assays, ensuring scientific rigor, robustness and regulatory compliance, and manage risk of externalization.
Establish operational plans for transfer of assays to external vendors, ensuring compliance, quality and timelines.
Execute robust insider/outsourcing strategy, selecting vendors through technical, strategic and scientific reviews, and track KPIs.
Optimize workflows to improve turnaround times, assay transfers, budgets and resource allocations.
Provide scientific oversight and guidance on data analysis, experimental design and regulatory submissions.
Represent the organization at scientific conferences and industry meetings.
Drive innovation using latest advances in platforms, assay design, data analysis, and AI in regulated environments.
Qualifications and Experience
Postgraduate degree (preferred PhD) with extensive experience in clinical biomarker / bioanalytical assays or related field.
8+ years of industry experience in a relevant academic or clinical environment.
Strong scientific background in Life Sciences with proven expertise in assay development, validation and regulatory guidance.
Demonstrated ability to manage cross‑functional, multicultural, and international teams.
Deep understanding of regulatory guidance and industry best practices.
Excellent analytical skills and ability to solve complex problems through investigation.
Strong communication and influencing skills.
Location & Employment Waltham, MA – Hybrid (onsite 3 days/week). Full‑time.
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Position Description Summary You will provide high‑level expertise and leadership in bioanalytical and biomarker assays, supporting non‑clinical and clinical studies. Lead the external tactical execution of assays to deliver innovative data sets that meet business needs. Your deep knowledge of assay design, regulatory standards, and industry best practices will guide validation of PK, ADA and biomarker assays. Excellent communication and influencing skills are essential for collaborating with internal stakeholders and external vendors.
Main Responsibilities
Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis aligned with company goals.
Lead, mentor and support scientists across functional groups in a matrix environment.
Participate in external due diligence and advise on assay quality, regulatory expectations and clinical/submission readiness.
Ensure timely support for project progression from non‑clinical development through all phases of clinical development, including submissions and post‑marketing requirements.
Direct the strategy and implementation of assays, ensuring scientific rigor, robustness and regulatory compliance, and manage risk of externalization.
Establish operational plans for transfer of assays to external vendors, ensuring compliance, quality and timelines.
Execute robust insider/outsourcing strategy, selecting vendors through technical, strategic and scientific reviews, and track KPIs.
Optimize workflows to improve turnaround times, assay transfers, budgets and resource allocations.
Provide scientific oversight and guidance on data analysis, experimental design and regulatory submissions.
Represent the organization at scientific conferences and industry meetings.
Drive innovation using latest advances in platforms, assay design, data analysis, and AI in regulated environments.
Qualifications and Experience
Postgraduate degree (preferred PhD) with extensive experience in clinical biomarker / bioanalytical assays or related field.
8+ years of industry experience in a relevant academic or clinical environment.
Strong scientific background in Life Sciences with proven expertise in assay development, validation and regulatory guidance.
Demonstrated ability to manage cross‑functional, multicultural, and international teams.
Deep understanding of regulatory guidance and industry best practices.
Excellent analytical skills and ability to solve complex problems through investigation.
Strong communication and influencing skills.
Location & Employment Waltham, MA – Hybrid (onsite 3 days/week). Full‑time.
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