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Job Description

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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

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.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Group Lead, Sample & Data Management in our Cambridge, MA location.

As Director, Group Lead, Sample & Data Management, you will be an enterprise level partner responsible for planning, coordinating, and overseeing all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens and data in support of Takeda clinical trials. You will support the management of high quality clinical bioanalytical and biomarker data and driving the process for data transfer from CROs to Takeda data repository and releasing reconciled data to end users.  You will serve as a conduit to the broader organization to help develop a framework, best practices, and efficiencies to drive standardization and simplification to enable connection of the translational strategy with operational planning and execution.

How you will contribute:

• The position requires working in close partnership across various Takeda functions including Translational Sciences within each Drug Discovery Unit and/or Therapeutic Area Unit, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance to build effective and strategic relationships.  
• Experience managing multiple bioanalytical and biomarker deliverables for concurrent clinical trials is required and expected to contribute at a broad and strategic level.
• Coordinate the bioanalytical and biomarker specimen strategy within multiple clinical programs observing the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP. 
• 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 and processing 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. 
• 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 trial endpoints.   
• 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 with a solid understanding of Quality Assurance requirements to ensure vendor compliance and data integrity. 
• Work with internal and external partners to develop processes and workflows for data flows, data mapping, data security and data QC as well as updating existing biomarker data standards for clinical trial studies.
• Work with clinical teams to provide controlled terminology and mapping instructions for clinical biomarker data and to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
• Work with Translational Scientists and BST SMEs to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
• Interface with clinical project teams to mitigate issues with clinical biomarker data standards as well as with vendors to mitigate issues with clinical biomarker data transfers, security, and reporting.
• Collaborate with Clinical Operations, clinical CRO, specialty and central laboratories to resolve sample and data reconciliation issues and maximize the quality of translational biomarker data as well as integrate clinical biomarker data sets with clinical EDC data for downstream biomarker data analysis.
• Participate in initiatives around data hosting and suitability of various databases for biomarker data from different modalities.
• Build and manage the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards.
• Work with QA on specialty lab vendor activities (new supplier requests, routine audits, technical assessment management, risk/mitigation).
• Work with Procurement on specialty lab vendor activities (onboarding, consolidation, RFI/RFP, pricing).
• Responsible for specialty lab vendor management at the partnership level (resource management, escalations, governance).
• Lead the coordination and support of audit and inspection preparation for both Takeda QA specialty lab audits as well as Agency inspections.
• Responsible for communication and to follow-up on any relevant matters related to specialty labs, Procurement, or Quality deliverables at the partnership level.
• Serve as a point of internal escalation for any specialty lab issues or critical path concerns that cannot be mitigated at the team level.
• Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities with a solid understanding of Quality Assurance and geographical requirements to ensure vendor compliance and data integrity.
• Participates in initiatives to create efficiencies and drive simplification in the execution of clinical testing paradigms. 

Minimum Requirements/Qualifications:

• PhD degree in a scientific discipline with 10+ years experience , or MS with 16+ years experience, or BS with 18+ years experience.
• 5 years of Industry experience required.
• 5 years of managerial experience required.
• Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.  
• Experience in sample and data 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.  
• Ability to be an effective member of multi-disciplinary project teams.

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. This position requires the candidate to come onsite to Cambridge location minimum 5x/month.

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:

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time