Strategic Lead, Translational Biomarkers & Bioanalytics

BioLife Plasma

Łódź

Hybrid

PLN 328,000 - 451,000

Full time

5 days ago

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Job summary

Takeda is seeking an Associate Director, Translational Biomarkers and Bioanalytics in Lodz, Poland. You will lead bioanalytical strategy, drive biomarker initiatives, and ensure compliant data generation for PK, immunogenicity, and biomarker assays across global clinical programs.

Strong vendor oversight and cross-functional collaboration are essential. You will navigate EU and Poland-specific regulatory guidance, oversee labs and CROs, and contribute to regulatory submissions while maintaining

Qualifications

PhD in a scientific discipline with 10+ years of experience, or MS with 16+ years, or BS with 18+ years, including 7+ years in industry.
Deep expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development.
Regulatory knowledge for bioanalytical method validation in EU/Poland and global contexts.

Responsibilities

Lead the bioanalytical strategy for global clinical development programs.
Provide scientific oversight of bioanalytical vendors and lifecycle management.
Ensure inspection readiness and data integrity across regulatory requirements.
Support regulatory submissions and health authority inquiries.
Collaborate with cross-functional teams across TB&B, QPTS, and Translational Medicine.