Associate Director, Translational Biomarkers and Bioanalytics

Takeda

Łódź

Hybrid

PLN 328,000 - 451,000

Full time

3 days ago

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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

Job Description

About the role:

As the Associate Director, Translational Biomarkers and Bioanalytics, you will serve as a scientific leader with deep bioanalytical and biomarker expertise, helping shape the strategy, build capabilities, and support the timely, compliant delivery of pharmacokinetic, immunogenicity, and biomarker data for clinical trials across global development programs.

You will act as an expert across one or more technologies, including mass spectrometry, and work closely with teams across TB&B and with partners in QPTS, Translational Medicine, Clinical Sciences, and GRA to advance clinical assets. You will apply fit-for-purpose and context-of-use principles, together with local, European Union, and global regulatory expectations, to support assay and biomarker strategies that enable high-quality portfolio decisions.

This role is based in Poland and includes awareness of local operational needs such as sample handling, shipment and export limits, and data requirements.

How you will contribute:

Lead the bioanalytical strategy and contribute to biomarker strategy for multiple global clinical development programs.
Independently design and deliver bioanalytical and biomarker work as a subject matter expert, ensuring regulated bioanalysis follows current global guidance and relevant local and European Union regulatory requirements.
Provide scientific and technical oversight of bioanalytical vendors, including global and, where relevant, Poland and European Union based vendors, for method development, optimization, validation, lifecycle management, and clinical sample testing across pharmacokinetic, immunogenicity, and biomarker assays.
Partner with Quality to support vendor qualification, audit readiness, and adherence to good practice requirements, while keeping work timely, scientifically sound, and ready for inspection.
Review pharmacokinetic, immunogenicity, and biomarker results; sample analysis reports; statistical analysis plans and outputs; and relevant sections of clinical study reports and submission documents.
Support regulatory submissions and interactions, including global submissions and, where relevant, Poland and European Union regulatory discussions.
Draft and support responses to health authority questions related to pharmacokinetic, immunogenicity, and biomarker data.
Serve as a Poland-based regulatory and quality subject matter expert for bioanalysis and biomarkers, including interpretation and application of local, European Union, and global regulations and guidance for method validation and sample testing.
Help ensure documentation, data integrity, and laboratory practices remain inspection-ready.
Align with study teams on compliant sample collection, storage, chain of custody, and cross-border shipment and export considerations.
Apply fit-for-purpose and context-of-use principles in biomarker development, including clinical feasibility assessments, assay validation approaches, and implementation plans.
Lead and coordinate a TB&B matrix team of subject matter experts and study logistics partners to plan and execute bioanalytical and biomarker deliverables according to study timelines.
Represent TB&B on cross-functional project teams and keep TB&B leadership informed of progress, risks, and mitigation plans.
Provide input to clinical and regulatory documents by consolidating subject matter expert feedback.
Support study start-up and database lock activities, including informed consent form and data transfer agreement reviews, sample reconciliation, data review and quality control, and data transfer.
Provide strategic bioanalysis and biomarker input to global project teams, including local and European Union regulatory or operational considerations as needed for a Poland-based role.
Lead immunogenicity risk assessment and mitigation planning from early development through commercialization across modalities and therapeutic areas.
Provide strategic recommendations on biomarker technologies and outputs aligned with study and program needs.
Share program updates with line leadership and study teams, and proactively manage and resolve issues while escalating critical risks and decisions in a timely manner.
Build a strong cross-functional network across Takeda and raise Takeda’s visibility through external bioanalysis and biomarker forums, scientific meetings, and publications.

Minimum Requirements/Qualifications:

Doctor of Philosophy in a relevant scientific discipline with 10 or more years of experience, or Master of Science with 16 or more years, or Bachelor of Science with 18 or more years, including 7 or more years of industry experience.
Deep expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development.
Strong expertise in one or more biomarker technologies, such as immunoassays, genomics, flow cytometry, cell-based assays, or liquid chromatography with tandem mass spectrometry, with current knowledge of scientific progress and best practices.
Current knowledge of global, European Union, and Poland-specific regulatory guidance for bioanalytical and biomarker method validation and clinical and preclinical sample testing.
Ability to translate local, European Union, and global regulatory expectations into fit-for-purpose bioanalytical plans, including inspection readiness, data integrity, and documentation standards.
Experience overseeing Poland and European Union based laboratories and contract research organizations, including vendor selection and qualification support, governance, deviation management, corrective and preventive action follow-up, and partnership with Quality.
Strong knowledge of related fields important to drug development, such as drug metabolism, pharmacology, toxicology, pharmaceutical sciences, and clinical bioanalysis.
Strong oral and written communication skills, including writing, reviewing, and editing scientific documents.
Demonstrated ability to work effectively on multidisciplinary, cross-functional project teams.
Strong collaboration and influencing skills with an enterprise mindset, with the ability to work in a highly matrixed environment and deliver through cross-functional partnerships.
Fluent in English; Polish language proficiency is preferred, with demonstrated ability to work effectively in local and global matrixed environments.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

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Locations

Lodz, Poland

Base Salary Range:

zł328,000.00 - zł451,000.00

For information about our benefits, please click here.

Locations

Lodz, Poland

Worker Type

Employee