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Job Description

About the role:

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. You will work with stakeholders within BST, PTS, and with partners across the business including Clinical Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker scientific operations and logistics with external vendors thereby helping create high quality clinical data.  

Accountabilities:

• The scientific manager will be accountable for project management and process-related strategies and deliverables for the BST sub-team and will work closely with the BST sub-team leader.
• The incumbent will oversee operational deliverables for different therapeutic modalities across the Takeda portfolio.
• Candidate will work in close partnership with the clinical biomarker, diagnostics, and bioanalytical sciences groups within BST.
• Work with study teams to develop clinical sample management plans, as well as review and contribute to clinical study protocols, informed consents, and central laboratory documents to ensure quality and accuracy. 
• Ensure biomarker specimen handling steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples. Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality. 
• Create and manage bioanalytical and biomarker operations program timelines, resources, and budget across multiple clinical programs.  
• The position also requires working in close partnership across various Takeda functions including Translational Sciences within each Drug Discovery Unit, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance.
• Experience managing multiple biomarker deliverables for concurrent clinical trials is required. 
• 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 for and managing timelines for various deliverables and facilitate communication between BST scientists and CRO labs as well as negotiate and ensure all high priority timelines for data delivery and reports are met.
• Responsible for bioanalytical and biomarker outsourcing strategy, vendor oversight and the management of priorities and study timelines for activities performed within CRO partnership agreements.
• 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, and other key functions within Takeda.
• Provide scientific support for defined programs, as needed.  

Education & Competencies:

• 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 with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy. 
• Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors. 
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China and Brazil) a plus. 
• Experience with Labmatrix or equivalent sample management software is a plus. 
• Proven critical reasoning skills including the identification and resolution of complex problems. 

More About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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