Senior Scientist, translational Biomarkers and Bioanalytics

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

Job summary

Takeda in Bengaluru, India, is seeking a Bioanalytical and Biomarker Senior Scientific Manager to drive bioanalytical and biomarker operations across global teams. The role focuses on enabling efficient execution from India, coordinating with BST and multiple drug discovery units across regions.

Responsibilities include leading project strategies, overseeing outsourcing, and ensuring data quality for clinical endpoints.

Qualifications

• 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.
• Proven critical reasoning skills including the identification and resolution of complex problems.

Responsibilities

• Lead project management and process-related strategies and deliverables for the BST sub-team, working with BST sub-team leaders and global stakeholders.
• Oversee operational deliverables for different therapeutic modalities across the Takeda portfolio, enabling efficient global execution from India.
• Collaborate with clinical biomarker, diagnostics, and bioanalytical sciences groups within BST.
• Partner across Takeda functions, including Translational Sciences, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance, for cross-region collaboration.
• Manage multiple biomarker deliverables for concurrent clinical trials.
• Contribute to bioanalytical and biomarker strategies in support of Takeda’s drug development projects across therapeutic areas.

Skills

Project management

Biomarker strategy

Regulatory knowledge

Communication skills

Ligand binding assays

LC/MS

qPCR

Flow cytometry

Immunohistochemistry

Education

PhD in scientific discipline

MS with 9+ years experience

BS with 11+ years experience

Tools

Vendor labs

QA & C knowledge

Job description

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: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified.

• 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.
• Coordinate assigned studies and programs by planning and managing timelines for key deliverables, facilitating communication between BST scientists and CRO labs, and ensuring high-priority timelines for data delivery and reports are met across regions.
• Responsible for bioanalytical and biomarker outsourcing strategy, vendor oversight, and management of priorities and study timelines for activities performed within CRO partnership agreements, including vendors supporting India and broader Asia-Pacific operations where applicable.
• Support the implementation, maintenance and improvement of preferred provider models used for bioanalytical outsourcing. Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities.
• Solid understanding of Quality Assurance requirements to ensure vendor compliance and data integrity.
• Support BST efforts to build effective and strategic relationships with QA&C, Clinical Operations, regional partners in India/Asia-Pacific, and other key functions within Takeda.
• Provide scientific support for defined programs, as needed.

Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.

• 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