Senior Leader, Translational Biomarkers & Bioanalytics

6999 Takeda SCE

Poland

Hybrid

PLN 328,000 - 451,000

Full time

14 days+
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Job summary

Takeda in Lodz, Poland, is seeking an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy across global clinical programs. You will optimize PK, immunogenicity, and biomarker data, applying fit‑for‑purpose concepts and EU regulations.

Mass spectrometry expertise and Poland awareness are important. You will supervise bioanalytical vendors, ensure inspection readiness, and support regulatory submissions while collaborating with TB&B, QPTS, Translational

Qualifications

  • Deep expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development.
  • Knowledge of regulatory guidance for method validation and sample testing.
  • Experience overseeing laboratories and CROs in EU contexts.

Responsibilities

  • Lead the bioanalytical strategy and biomarker work for global clinical programs.
  • Provide scientific oversight of vendors for method development and validation.
  • Support regulatory submissions and health authority interactions.
  • Align with cross-functional teams on sample handling, data integrity, and inspection readiness.
  • Represent the function in Poland and EU regulatory discussions.

Skills

bioanalytical chemistry
immunology
biomarker technologies
regulatory guidance
vendor management
communication skills
English fluency
Polish preferred

Education

PhD in a relevant field

Tools

Mass spectrometry

Job description

Takeda in Lodz, Poland, is seeking an Associate Director, Translational Biomarkers and Bioanalytics to lead bioanalytical strategy across global clinical programs. You will optimize PK, immunogenicity, and biomarker data, applying fit‑for‑purpose concepts and EU regulations.

Mass spectrometry expertise and Poland awareness are important. You will supervise bioanalytical vendors, ensure inspection readiness, and support regulatory submissions while collaborating with TB&B, QPTS, Translational

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