Assoc. Director, Translational Biomarkers & Bioanalytics

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

Benefits offered by this job

Hybrid work model

Global Top Employer recognition

Job summary

Takeda in Łódź, Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics, to lead bioanalytical and biomarker strategies across global programs. You will oversee vendors, ensure compliance with EU/Poland standards, and collaborate with cross-functional teams to drive high-quality data for regulatory submissions.

You will contribute to vaccine or drug development through PK, immunogenicity, and biomarker analyses, aligning with study timelines and inspection readiness in a

Qualifications

• PhD in a relevant 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.
• Strong biomarker technology knowledge (immunoassays, genomics, flow cytometry, etc.).
• Current knowledge of global, EU, and Poland-specific regulatory guidance for method validation and testing.
• Ability to translate regulatory expectations into fit-for-purpose bioanalytical plans and inspection readiness.
• Experience overseeing Poland/EU labs and CROs, including vendor qualification and governance.
• Strong knowledge of drug metabolism, pharmacology, toxicology, pharmaceutical sciences, and clinical bioanalysis.
• Strong communication skills; capable of writing and editing scientific documents.
• Proven ability to work in multidisciplinary, cross-functional teams.
• Strong collaboration and influencing skills with an enterprise mindset.
• Fluent in English; Polish proficiency preferred for local/global matrixed work.

Responsibilities

• Lead bioanalytical strategy and biomarker strategy for global programs.
• Design and deliver bioanalytical work as SME ensuring regulated bioanalysis meets global and EU requirements.
• Provide scientific oversight of bioanalytical vendors for method development, validation, and testing.
• Partner with Quality for vendor qualification and audit readiness; ensure inspection readiness.
• Review PK, immunogenicity, and biomarker results and related documents.
• Support regulatory submissions and health authority interactions.
• Draft responses to health authority questions on PK, immunogenicity, and biomarkers.
• Serve as Poland-based regulatory/quality SME for bioanalysis and biomarkers.
• Ensure documentation, data integrity, and laboratory practices are inspection-ready.
• Align sample collection, storage, chain of custody, and cross-border shipments.
• Apply fit-for-purpose biomarker development and validation approaches.
• Lead TB&B matrix team for bioanalytical deliverables and timelines.
• Represent TB&B on cross-functional projects and update leadership.
• Provide input to clinical/regulatory documents with SME feedback.
• Support study start-up and data transfer activities; ensure data quality.
• Provide strategic bioanalysis input to global project teams including EU/regulatory needs.
• Lead immunogenicity risk assessment and mitigation planning.
• Recommend biomarker technologies aligned with study needs.
• Share program updates and manage risks; escalate as needed.
• Build cross-functional network and raise Takeda’s profile in external forums.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Regulatory guidance knowledge

Cross-functional collaboration

English fluency

Education

PhD in relevant science

MS in relevant field

BS in relevant field

Tools

Mass spectrometry

LC-MS/MS

Job description

Takeda in Łódź, Poland, seeks an Associate Director, Translational Biomarkers and Bioanalytics, to lead bioanalytical and biomarker strategies across global programs. You will oversee vendors, ensure compliance with EU/Poland standards, and collaborate with cross-functional teams to drive high-quality data for regulatory submissions.

You will contribute to vaccine or drug development through PK, immunogenicity, and biomarker analyses, aligning with study timelines and inspection readiness in a