Principal Scientist, Clinical Assay Strategy X3

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 Principal Scientist 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 Director of Clinical Assay.

Position Description Summary:

You will part of a specialized non-laboratory based team and provide high level expertise in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will support the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Broad 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 externalisation of compliant bioanalytical and biomarker assays . The candidate will need to have a solid understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms assay types and context of use.

Main Responsibilities:

Leadership and Strategy
Implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the companys overall goals and objectives focusing on non clinical development programs and clinical programs with known/standard bioanalytical/biomarker requirements.
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 implementation of bioanalytical/biomarker assays ensuring scientific rigor robustness and regulatory compliance. Identify and proactively manage risk with externalisation of critical bioassays.
Implement 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 insourcing outsourcing strategy ensuring strategic decisions and effective utilisation 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 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:

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 experience in a relevant academic environment.
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 including assay development validation and conduct to support clinical studies.

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Our 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. 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 whats available to you as a CSL employee.

About CSL Behring

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

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.

Do work that matters at CSL Behring!