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About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

The Scientific Manager, Scientist I, Biomarker Science & Technologies 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.

How you will contribute:

• 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.

• 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.

• Success in these responsibilities requires an understanding of disease biology, strategic thinking, attention to detail, and experience in drug development.

• 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 would be beneficial for success in role.

• 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.

• Contributes to bioanalytical and biomarker outsourcing strategy, vendor oversight and manages priorities and study timelines for activities performed within CRO partnership agreements.

• 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.

Minimum Requirements/Qualifications:

• PhD degree in a scientific discipline, or MS with 6+ years experience, or BS with 8+ 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" in accordance with 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.

For Location:

U. S. Base Salary Range: