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CSL · 2 days ago

Associate Director, Clinical Assay

Greater Boston

Full-time

Hybrid

Lead/Staff, Director/Executive

8+ years exp

CSL is a leading biotechnology company focused on delivering innovative therapies for patients. The Associate Director of Clinical Assay will provide expertise in bioanalytical and biomarker assays to support clinical studies, ensuring compliance with regulatory standards and effective collaboration with cross-functional teams.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

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

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

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 turnaround times, assay transfers, budgets, and resource allocation

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

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

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

Qualification

Bioanalytical assaysBiomarker assaysRegulatory complianceClinical studiesProject managementAnalytical skillsLeadershipCollaborationCommunication skills

Required

Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field, Hematology/CVR/Transplant/Immunology

8+ 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