Senior Scientist, translational Biomarkers and Bioanalytics

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Objective / Purpose: Describe at the highest level the team where this job sits and how this role will contribute to the teams 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 Takedas 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 Takedas 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.