Associate Director, Translational Biomarkers and Bioanalytics
Takeda · Warsaw · PLN 328,000–PLN 451,000 (stated in the posting)
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.