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Job Description
About the role:
As the Associate Director, Translational Biomarkers and Bioanalytics, you will serve as a scientific leader with deep bioanalytical and biomarker expertise, helping shape the strategy, build capabilities, and support the timely, compliant delivery of pharmacokinetic, immunogenicity, and biomarker data for clinical trials across global development programs.
You will act as an expert across one or more technologies, including mass spectrometry, and work closely with teams across TB&B and with partners in QPTS, Translational Medicine, Clinical Sciences, and GRA to advance clinical assets. You will apply fit-for-purpose and context-of-use principles, together with local, European Union, and global regulatory expectations, to support assay and biomarker strategies that enable high-quality portfolio decisions.
This role is based in Poland and includes awareness of local operational needs such as sample handling, shipment and export limits, and data requirements.
How you will contribute:
Lead the bioanalytical strategy and contribute to biomarker strategy for multiple global clinical development programs.
Independently design and deliver bioanalytical and biomarker work as a subject matter expert, ensuring regulated bioanalysis follows current global guidance and relevant local and European Union regulatory requirements.
Provide scientific and technical oversight of bioanalytical vendors, including global and, where relevant, Poland and European Union based vendors, for method development, optimization, validation, lifecycle management, and clinical sample testing across pharmacokinetic, immunogenicity, and biomarker assays.
Partner with Quality to support vendor qualification, audit readiness, and adherence to good practice requirements, while keeping work timely, scientifically sound, and ready for inspection.
Review pharmacokinetic, immunogenicity, and biomarker results; sample analysis reports; statistical analysis plans and outputs; and relevant sections of clinical study reports and submission documents.
Support regulatory submissions and interactions, including global submissions and, where relevant, Poland and European Union regulatory discussions.
Draft and support responses to health authority questions related to pharmacokinetic, immunogenicity, and biomarker data.
Serve as a Poland-based regulatory and quality subject matter expert for bioanalysis and biomarkers, including interpretation and application of local, European Union, and global regulations and guidance for method validation and sample testing.
Help ensure documentation, data integrity, and laboratory practices remain inspection-ready.
Align with study teams on compliant sample collection, storage, chain of custody, and cross-border shipment and export considerations.
Apply fit-for-purpose and context-of-use principles in biomarker development, including clinical feasibility assessments, assay validation approaches, and implementation plans.
Lead and coordinate a TB&B matrix team of subject matter experts and study logistics partners to plan and execute bioanalytical and biomarker deliverables according to study timelines.
Represent TB&B on cross-functional project teams and keep TB&B leadership informed of progress, risks, and mitigation plans.
Provide input to clinical and regulatory documents by consolidating subject matter expert feedback.
Support study start-up and database lock activities, including informed consent form and data transfer agreement reviews, sample reconciliation, data review and quality control, and data transfer.
Provide strategic bioanalysis and biomarker input…