R-290721 Associate Director Clinical Assay Strategy

CSL Plasma•Waltham, MA

About The Position

The incumbent will be part of a specialized 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 excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross-functional teams and execute externalization of compliant bioanalytical and biomarker assays. The candidate will need to have a deep understanding of the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types, and context of use.

Requirements

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.

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 externalization 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 utilization 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.
Interpretation of moderate complexity data, ability to troubleshoot and define next steps across areas of expertise for often complex issues.
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.
Stay updated on advancements throughout the field to support current and emerging modalities.