Senior Translational Biomarkers & Bioanalytics Lead

POL - 6999 Takeda SCE; Łódź; Hybrid; PLN 328,000 - 451,000; Full time

Job summary

Takeda Poland seeks an Associate Director, Translational Biomarkers and Bioanalytics, to guide bioanalytical strategy for global clinical programs. You will contribute expert design, validation, and biomarker work while ensuring regulatory compliance and cross-functional collaboration across teams.

Based in Poland with a hybrid work model, you will oversee vendors, support regulatory submissions, and align with global and EU requirements to deliver high-quality PK, immunogenicity, and biomarker

Qualifications

• PhD in a relevant discipline with 10+ years of experience, or MS with 16+ years, or BS with 18+ years.
• Deep expertise in bioanalytical chemistry, immunology, and bioanalytical techniques.
• Current knowledge of regulatory guidance for bioanalytical method validation and testing.
• Experience overseeing Poland/EU labs and CROs, vendor governance, and QA collaboration.
• Strong written and oral communication; ability to work in global matrix environments.

Responsibilities

• Lead bioanalytical strategy for global clinical programs.
• Oversee method development, validation, lifecycle management, and testing.
• Provide oversight of vendors and QA collaboration for inspections.
• Support regulatory submissions and health authority responses.
• Ensure data integrity and inspection readiness across studies.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Regulatory knowledge

Vendor management

Cross-functional collaboration

Scientific writing

English fluency

Education

PhD in science

MS in science

BS in science

Tools

LC-MS/MS

Immunoassays

Genomics

Flow cytometry

Cell-based assays

Job description

Takeda Poland seeks an Associate Director, Translational Biomarkers and Bioanalytics, to guide bioanalytical strategy for global clinical programs. You will contribute expert design, validation, and biomarker work while ensuring regulatory compliance and cross-functional collaboration across teams.

Based in Poland with a hybrid work model, you will oversee vendors, support regulatory submissions, and align with global and EU requirements to deliver high-quality PK, immunogenicity, and biomarker