MEX - 9930 Takeda Innovation Solutions Mexico S.A de C.V
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Hybrid · Łódź, Łódź Voivodeship, PolandPLN 328k–451kFull-timeUpdated 4 weeks ago
MEX - 9930 Takeda Innovation Solutions Mexico S.A de C.V
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As Associate Director, Mass Spectrometry, Translational Biomarkers and Bioanalytics, you will lead bioanalytical and biomarker strategy for global clinical development programs. You will help build capabilities, shape scientific direction, and ensure timely, compliant delivery of pharmacokinetic, immunogenicity, and biomarker data that support clinical decisions across development programs. You will serve as a scientific expert in mass spectrometry and in one or more related technologies, and you will work closely with Translational Biomarkers and Bioanalytics, Translational Medicine, Clinical Sciences, Quality, and Regulatory Affairs teams.
This Poland-based role also includes attention to local, European Union, and global requirements for sample handling, shipment, export, and data documentation.
Lead bioanalytical strategy and contribute to biomarker strategy across multiple global clinical development programs.
Design and deliver bioanalytical and biomarker work as the subject matter expert, ensuring regulated bioanalysis follows current global guidance and applicable local and European Union requirements.
Provide scientific and technical oversight of bioanalytical vendors for method development, optimization, validation, lifecycle management, and clinical sample testing across gastrointestinal and inflammatory diseases, neuroscience, and oncology.
Partner with Quality to support vendor qualification, audit readiness, data integrity, deviation management, corrective and preventive actions, and inspection readiness.
Review pharmacokinetic, immunogenicity, and biomarker results, sample analysis reports, statistical analysis plans, outputs, and relevant sections of clinical study reports and submission documents.
Support regulatory submissions and health authority responses, including documents such as briefing books, investigator brochures, investigational new drug and clinical trial applications, investigational medicinal product dossiers, and common technical documents.
Apply local, European Union, and global regulatory principles to method validation, sample testing, documentation, and laboratory practices.
Support compliant sample collection, storage, chain of custody, and cross-border shipment and export planning for study teams.
Apply fit-for-purpose and context-of-use principles to biomarker development, including feasibility assessments, assay validation approaches, and implementation plans.
Lead and coordinate a matrix team of subject matter experts and study logistics partners to plan and execute deliverables to study timelines.
Represent Translational Biomarkers and Bioanalytics on cross-functional project teams and keep leadership informed of progress, risks, and mitigation plans.
Provide input to clinical and regulatory documents by consolidating subject matter expert feedback and supporting study start-up and database lock activities.
Lead immunogenicity risk assessment and mitigation planning from early development through commercialization across modalities and therapeutic areas.
Recommend biomarker technologies and outputs based on program needs and scientific fit.
Share program updates with line leadership and study teams, and raise critical issues and decisions in a timely way.
Build strong connections across Takeda by contributing to external bioanalysis and biomarker forums, presenting at scientific meetings, and supporting publications.
Doctor of Philosophy in a relevant scientific discipline with 10 or more years of experience, Master of Science with 16 or more years of experience, or Bachelor of Science with 18 or more years of experience, including 7 or more years in industry.
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 guidance for bioanalytical and biomarker method validation and clinical and preclinical sample testing.
Experience translating local, European Union, and global regulatory expectations into fit-for-purpose bioanalytical plans with strong attention to inspection readiness, data integrity, and documentation.
Experience overseeing Poland or European Union laboratories or 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 that support drug development, such as drug metabolism, pharmacology, toxicology, pharmaceutical sciences, and clinical bioanalysis.
Strong written and verbal communication skills, including the ability to write, review, and edit scientific documents.
Proven ability to work well on multidisciplinary, cross-functional project teams.
Strong collaboration and influencing skills in complex matrix environments.
Fluency in English; Polish language skills are preferred.
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.
