CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels 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.
Position Description Summary:
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., focussing 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 externalisation 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.
Qualifications and Experience Requirements:
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. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
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. Learn more Inclusion and Belonging | CSL.