Associate Director Mass Spectrometry

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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 mass spectrometry (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 EU 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/EU regulatory requirements where relevant and reflects local operational considerations for a 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/EU-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 EU 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 EU 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 a India-based regulatory and quality SME for bioanalysis/biomarkers: interpret and apply local EU 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/EU 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 EU and India-specific regulatory guidance for bioanalytical/biomarker method validation and clinical/preclinical sample testing.
• Demonstrated ability to operationalizelocal EU and global regulatory expectations into fit-for-purpose bioanalytical plans including inspection readiness data integrity and documentation standards.
• Experience overseeingIndia/EU-based 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; Indian language proficiency is preferred with demonstrated ability to operate effectively in local and global matrixed environment

Benefits

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

Competitive Salary Performance Annual Bonus

• Flexible work environment including hybrid working
• Comprehensive Healthcare Insurance Plans for self spouse and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity Equity and Inclusion Programs
• No Meeting Days
• Reimbursements Home Internet & Mobile Phone
• Employee Referral Program
• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 days)

About ICC in Takeda

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.
• As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

Locations

Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time