Director Clinical Assay Strategy, Hematology and Cardiovascular & Renal

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 Director Clinical Assay Strategy? 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 Senior Director, Global Lead and Head Research and Clinical Bioanalytics.

You will lead a specialized non-laboratory based team and provide high level expertise and leadership capacity in area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role requires a strategic vision coupled with tactical execution to ensure delivery of innovative assays and key data sets to meet the business needs (1-2 years). Deep understanding of assay design, regulatory standards and industry best practices are essential. This role requires high excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams and execute successful transfer assays to external vendors. The incumbent will collaborate with non-clinical and clinical development teams to provide strategic bioanalytical and biomarker support for trial design and execution; including protocol development, development of bioanalytical/biomarker strategies, and designing assays to achieve clinical and research objectives. 

Main Responsibilities:

Leadership and Strategy​
Lead the development and implementation of bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company’s overall goals and objectives., focusing on complex projects that require high level of experience and expertise.​
Lead and mentor a team of clinical bioanalytical/biomarkers strategy scientists, 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. ​
Lead and provide oversight to the externalization of compliant bioassays, accountable for ensuring assays at external partners are validated to required regulatory requirements and context of use, sample analysis is of highest quality and reported within project timelines.​

Project and Resource Management​
Work with Clinical Bioanalytics and Biomarker leadership team to execute robust insourcing outsourcing strategy, ensuring strategic decisions and effective utilization of available resources.​
Direct the selection of vendors through in depth technical, strategic and scientific review. Lead governance meetings, point of escalation for issues and tracking of KPIs.​
Optimize workflows to ensure optimal turn around times, assay transfers, budgets, and resource allocation.​

Scientific Oversight​
Recognized subject matter expert in job area  typically obtained through advanced education and work experience.​
Provide scientific guidance and expertise to the Clinical Translational team and more broadly 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, and participating in regulatory meetings as needed.​
Communicate scientific results clearly and concisely to appropriate audiences.​

Collaboration and Networking​
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.​

Innovation and Technology​
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.​