Senior Translational Biomarkers & Bioanalytics Lead

Takeda; Warszawa; Hybrid; PLN 328,000 - 451,000; Full time

Job summary

Takeda, based in Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy and biomarker development across global clinical programs. You will oversee methods, validation, and testing, ensuring compliance with local and EU regulations while coordinating with vendors and cross-functional teams.

You will support regulatory submissions and health authority interactions, and help align study plans with quality and data integrity standards in a

Qualifications

• PhD in a relevant scientific discipline with 10+ years of experience, or MSc with 16+ years, or BSc with 18+ years and 7+ years in industry.
• Deep expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development.
• Strong biomarker technology expertise such as immunoassays, genomics, flow cytometry, cell-based assays, or LC-MS/MS.

Responsibilities

• Lead bioanalytical strategy and contribute to biomarker strategy for global programs.
• Design and deliver bioanalytical work as SME, ensuring compliant bioanalysis per global and local regulations.
• Provide oversight of bioanalytical vendors for method development, validation, and testing.
• Support vendor qualification, audits, and regulatory compliance activities.
• Review PK, immunogenicity, biomarker results and study reports.
• Support regulatory submissions and health authority inquiries.
• Serve as Poland-based regulatory/quality SME for bioanalysis and biomarkers.
• Ensure documentation and data integrity aligned with inspection readiness.
• Align sample collection, storage, chain of custody, and cross-border shipment considerations.
• Lead a TB&B matrix team to plan and execute deliverables on study timelines.
• Represent TB&B on cross-functional teams and inform leadership of progress and risks.
• Provide strategic biomarker input to global project teams considering local and EU requirements.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Analytical development

Regulatory guidance

Education

Doctor of Philosophy in a relevant scientific discipline

Master of Science

Bachelor of Science

Tools

Mass spectrometry

Immunoassays

Flow cytometry

LC-MS/MS

Job description

Takeda, based in Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy and biomarker development across global clinical programs. You will oversee methods, validation, and testing, ensuring compliance with local and EU regulations while coordinating with vendors and cross-functional teams.

You will support regulatory submissions and health authority interactions, and help align study plans with quality and data integrity standards in a