Senior Scientist, translational Biomarkers and Bioanalytics

IND - 2028 Takeda Innovations India Private Limited; Karnataka; On-site; INR 3,800,000 - 5,200,000; Full time

Job summary

Takeda is seeking a Bioanalytical and Biomarker Senior Scientific Manager in Bengaluru, India. This role sits within the Biomarker Science and Technologies (BST) department of Preclinical and Translational Sciences and supports BST and PTS stakeholders globally.

Responsibilities include leading biomarker deliverables across modalities, coordinating with clinical biomarker and bioanalytical groups, and ensuring regulatory compliance and data quality across Takeda’s portfolio.

Qualifications

• PhD with 3+ years experience or MS with 9+ years or BS with 11+ years in drug development.
• Experience in sample management across multiple projects.
• Ability to work with diverse scientists, clinicians, vendor labs and global teams.

Responsibilities

• Lead project management and process strategies for the BST sub-team.
• Oversee operational deliverables across modalities from India.
• Partner with clinical biomarker, diagnostics, and bioanalytical groups.
• Collaborate with Clinical Operations, Data Solutions and Quality Assurance.
• Drive bioanalytical and biomarker strategies in drug development.
• Ensure compliance with FDA and ICH/GCP in clinical studies.

Skills

Regulatory knowledge FDA & ICH/GCP

Cross-functional collaboration

Critical reasoning

Communication skills

Education

PhD degree in a scientific discipline

MS degree

BS degree

Job description

Objective / Purpose: Describe at the highest level the team where this job sits and how this role will contribute to the team’s delivery of critical function. The Bioanalytical and Biomarker Senior Scientific Manager is an exciting, high-impact role within the Biomarker Science and Technologies (BST) department within Preclinical and Translational Sciences (PTS) at Takeda. Based in India, this role will provide global support to BST and PTS stakeholders and partner closely with colleagues across Clinical Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, Clinical Data Solutions, and external vendors to enable efficient clinical bioanalytical and biomarker scientific operations and logistics, thereby helping generate high-quality clinical data across Takeda’s portfolio.

Accountabilities:

• The Scientific Manager will be accountable for project management and process-related strategies and deliverables for the BST sub-team, working closely with BST sub-team leaders and global stakeholders.
• The incumbent will oversee operational deliverables for different therapeutic modalities across the Takeda portfolio, with a focus on enabling efficient global execution from India.
• Candidate will work in close partnership with the clinical biomarker, diagnostics, and bioanalytical sciences groups within BST.
• The position also requires close partnership across Takeda functions, including Translational Sciences within each Drug Discovery Unit, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance, while supporting effective collaboration across global time zones.
• Experience managing multiple biomarker deliverables for concurrent clinical trials is required.
• Contributes at a broad and strategic level by executing and overseeing the bioanalytical and biomarker strategies in support of Takeda’s drug development projects across all therapeutic areas.
• Success in these responsibilities requires an understanding of disease biology, strategic thinking, attention to detail, and experience in drug development.
• Candidate should have a working knowledge of various analytical methods including ligand binding assays, LC/MS, qPCR, flow cytometry and immunohistochemistry as well as a working knowledge of fit-for-purpose assay rigor (qualification, validation, etc) requirements needed to support clinical endpoints.

Education & Competencies (Technical and Behavioral):

• PhD degree in a scientific discipline with 3+ years experience , or MS with 9+ years experience, or BS with 11+ years experience Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.
• Experience in sample management activities across multiple projects.
• Ability to work effectively with a diverse group of scientists, clinicians, vendor labs, and internal and external partners across India, Asia-Pacific, and global Takeda teams to support product strategy.
• Excellent written, organizational, and interpersonal communication skills to efficiently and succinctly update stakeholders and internal team members, address questions and issues, interface with external vendors, and collaborate effectively across global time zones.
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
• Knowledge of India clinical trial and laboratory regulations, as well as regulations from other regions such as China and Brazil, is a plus.
• Proven critical reasoning skills including the identification and resolution of complex problems.

Locations IND - Bengaluru - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time

Takeda is an equal opportunity employer.