Senior Bioanalytics & Biomarker Strategy Lead

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

Benefits offered by this job

Hybrid work arrangement

Job summary

Takeda Pharmaceutical Co. in Poland is seeking an Associate Director, Translational Biomarkers and Bioanalytics, to lead bioanalytical strategy across global clinical programs, ensuring regulatory readiness and data integrity.

You will oversee vendors, collaborate with cross-functional teams, and shape biomarker strategies, with emphasis on EU and Poland regulatory guidance, sample handling, and inspection readiness.

Qualifications

• Doctoral degree with 10+ years, or MS with 16+ years, or BS with 18+ years including 7+ years in industry.
• Deep expertise in bioanalytical chemistry, immunology, and drug development.
• Expertise in one or more biomarker technologies and regulatory knowledge.
• Ability to translate global regulatory guidance into bioanalytical plans.

Responsibilities

• Lead the bioanalytical strategy for global clinical programs.
• Design and deliver bioanalytical work as SME while ensuring compliant bioanalysis.
• Oversee bioanalytical vendors including Poland/EU labs.
• Support regulatory submissions and interactions for global programs.
• Review PK, immunogenicity, and biomarker results and reports.
• Lead immunogenicity risk assessment and mitigation planning.
• Represent TB&B on cross-functional project teams and communicate progress.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Cross-functional collaboration

Regulatory knowledge

Education

PhD in a relevant scientific discipline

MS in a relevant field

BS in a relevant field

Tools

Mass spectrometry

Genomics

Flow cytometry

LC-MS/MS

Job description

Takeda Pharmaceutical Co. in Poland is seeking an Associate Director, Translational Biomarkers and Bioanalytics, to lead bioanalytical strategy across global clinical programs, ensuring regulatory readiness and data integrity.

You will oversee vendors, collaborate with cross-functional teams, and shape biomarker strategies, with emphasis on EU and Poland regulatory guidance, sample handling, and inspection readiness.