Associate Director - Immunoassay

Takeda; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Takeda in Bengaluru seeks a Scientific leader to shape bioanalytical and biomarker strategy across global programs, ensuring timely, compliant data delivery for PK, immunogenicity, and biomarker analyses.

You will oversee method development, validation, lifecycle management, and regulatory submissions, partnering with cross-functional teams and India-based labs to ensure inspection-ready documentation and data integrity.

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 of industry experience).
• In-depth expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in drug development.
• Expertise in biomarker technologies (immunoassays, genomics, flow cytometry, cell-based assays, LC-MS/MS).
• Knowledge of global and India regulatory guidance for bioanalytical/biomarker method validation and clinical testing.
• Experience overseeing India-based and global laboratories/CROs and vendor management.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Immunoassays

Genomics

Flow cytometry

Cell-based assays

LC-MS/MS

Regulatory guidance

Vendor management

Cross-functional collaboration

English communication

Education

PhD in a relevant scientific discipline

MS with 16+ years

BS with 18+ years

Job description

Job Description

Objective / Purpose:

Scientific leader with deep bioanalytical and biomarker expertise, accountable for building capabilities, shaping the strategic direction for bioanalytical and biomarker development and implementation, and ensuring timely, compliant delivery of PK, immunogenicity, and biomarker data for clinical trials across global development programs. Serves as an expert across one or more technologies with one of them being immunoassay (e.g., immunoassays, cell-based assays, flow cytometry, LC-MS/MS, and genomics) and partners closely within TB&B and with cross-functional stakeholders (e.g., QPTS, Translational Medicine, Clinical Sciences, GRA) to advance clinical assets. Applies fit-for-purpose, context-of-use, and relevant local, India, and global regulatory principles to assay and biomarker strategies that enable timely, high-quality portfolio decisions.

Accountabilities:

• Lead the bioanalytical strategy and contribute to biomarker strategy for multiple global clinical development programs. Independently design and execute deliverables as the bioanalytical and biomarker SME, ensuring regulated bioanalysis meets current global guidance and applicable local/India regulatory requirements where relevant and reflects local operational considerations for an India-based role (e.g., sample handling, shipment/export limitations, and data requirements).
• Provide scientific and technical oversight of bioanalytical vendors (global and, where applicable, India-based) for method development, optimization, validation, lifecycle management (PK, immunogenicity, biomarkers), and clinical sample testing supporting development and post-market commitments across GI&I, NS and Oncology. Partner with Quality to ensure vendor qualification, audit readiness, and adherence to GxP and applicable local, India, and global regulations; ensure delivery is timely, scientifically sound, and inspection-ready.
• Provide SME support for data analysis and regulatory submissions, including global submissions and, where relevant, India regulatory interactions. Review PK, immunogenicity, and biomarker results; sample analysis reports; statistical analysis plans and outputs; and relevant sections of CSRs and submission documents (e.g., ISI, IND, briefing books, IB, IMPD/CCD, CTD). Draft and support responses to health authority questions related to PK, immunogenicity, and biomarkers.
• Serve as an India-based regulatory and quality SME for bioanalysis/biomarkers: interpret and apply local, India, and global regulations and guidance for method validation and sample testing; ensure documentation, data integrity, and laboratory practices are inspection-ready; and align with study teams on compliant sample collection, storage, chain-of-custody, and cross-border shipment/export considerations.
• Apply fit-for-purpose and context-of-use principles in biomarker development, including clinical feasibility assessments, assay validation approaches, and implementation strategies to deliver key assays and data that inform portfolio and program decisions.
• Lead and coordinate a TB&B matrix team of subject matter experts and study logistics partners to plan and execute bioanalytical/biomarker deliverables in accordance with 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 relevant clinical and regulatory documents by consolidating SME feedback (e.g., protocols, IND/NDA/BLA submissions, briefing books, IB, CSR) and support study start-up and database lock activities (e.g., ICF and data transfer agreements, sample reconciliation, data review/QC, and data transfer).
• Provide strategic bioanalysis and biomarker input and scientific expertise to global project teams, including local/India regulatory or operational considerations as needed for an India-based role, and 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 stakeholder needs.
• Provide program updates to the line leadership and study teams. Proactively manage and resolve issues, escalating critical risks and decisions in a timely manner.
• Build a strong cross-functional network across Takeda and enhance Takeda visibility by participating in external bioanalysis/biomarker forums, presenting at scientific meetings, and contributing to publications.

Education & Competencies (Technical and Behavioral):

• PhD in a relevant scientific discipline with 10+ years of experience, or MS with 16+ years, or BS with 18+ years (including 7+ years of industry experience).
• In-depth expertise in bioanalytical chemistry, immunology, and bioanalytical techniques in the context of drug development.
• Outstanding expertise in one or more biomarker technologies (e.g., immunoassays, genomics, flow cytometry, cell-based assays, LC-MS/MS), with a current understanding of scientific advancements and evolving best practices.
• Current knowledge of global and India-specific regulatory guidance for bioanalytical/biomarker method validation and clinical/preclinical sample testing.
• Demonstrated ability to operationalize local, India, and global regulatory expectations into fit-for-purpose bioanalytical plans, including inspection readiness, data integrity, and documentation standards.
• Experience overseeing India-based and global laboratories/CROs, including vendor selection/qualification support, governance, deviation management, CAPA follow-up, and partnership with Quality.
• Strong knowledge of allied fields critical to drug development (e.g., drug metabolism, pharmacology, toxicology, pharmaceutical sciences, and clinical bioanalysis). Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.
• Demonstrated ability to work effectively on multi-disciplinary, cross-functional project teams.
• Excellent collaboration and influencing skills with an enterprise mindset; able to navigate highly complex, matrixed environments to align stakeholders and deliver through strong cross-functional partnerships.
• Fluent in English; Polish language proficiency is preferred, with demonstrated ability to operate effectively in local and global matrixed environments.

Locations

IND - Bengaluru - Research and Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time