R-290721 Associate Director Clinical Assay Strategy

The Opportunity:

The incumbent will part of a specialised non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies.

This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep 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 deep understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types and context of use.

The Role:

Leadership and Strategy

• Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company’s overall goals and objectives, supporting clinical programs with moderate complexity.
• 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 strategy and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance. 
• Identify and proactively manage risk with externalisation of critical bioassays.
• Establish 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.

Skills and Experience:

• Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays  or a related field.

• Minimum of 5-10 years' relevant industry experience and / or equivalent experience in a relevant academic environment.

• Strong and proven scientific background in relevant Life Sciences discipline..

• Demonstrated ability in managing highly effective teams that are cross-functional, multicultural and international.

• Deep understanding of relevant regulatory guidance’s and industry best practices.

• Excellent analytical skills, ability to address complex problems through investigation and analysis.

• Outstanding written and verbal communication skills, with the ability to present complex scientific concepts to diverse audiences.
• Strong networking skills and proven experience managing external partners.

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 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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.