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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 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.

Join Takeda as a Clinical Biomarker Sample Operations Senior Manager in Cambridge, MA, where you will act as an enterprise level partner responsible for the lifecycle management of clinical bioanalytical (PK, ADA) and biomarker samples, data, and specialty lab vendors to maintain chain-of-custody in a GxP-compliant setting.  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.

As part of the Biomarker Science & Technologies (BST) group at Takeda, you will report to the Head of Sample and Data Operations, Director and you will will work to advance the mission of BST and its contributions to the clinical program lifecycle.

How you will contribute:                        

• Support the planning and coordination of clinical sample activities required to manage the lifecycle of biospecimen samples (e.g., collection, shipping, processing, analysis, data delivery and cleaning, and final sample disposition).
• Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximize biomarker specimen accrual and quality.
• Develop robust processes to facilitate the planning, coordination, and oversight of all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition).
• Helps to develop best practices for resolution of biosample related data reconciliation and sample related activities (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition) in collaboration with relevant stakeholders including Data Management, Clinical Operations and Quality Assurance. 
• Utilize sample and data management automated tools to help define the process for data reconciliation of clinical biomarker samples and datasets to ensure adherence to the clinical study protocol, patient consent and data transfer specifications.
• Collaborate with Clinical Operations, clinical CRO, specialty and central laboratories to resolve sample and data reconciliation issues in a timely manner and maximize the quality of translational biomarker data.
• Collaborate with all team functions to design and operationalize a seamless process spanning from vendor onboarding, sample tracking and analysis, to data delivery and management.
• Work with 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, including ICH/GDPR/GCP/IVDR/GLP. 
• Responsible for developing and maintaining metrics for specialty lab vendor management at the partnership level, as well as overseeing escalations, governance).
• Help to maintain MSAs, legal agreements, and contracts related to BST activities, specialty labs, and partnerships.
• Support the coordination and support of audit and inspection preparation for both Takeda QA specialty lab audits as well as Agency inspections.
• 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 and identifies and contributes to areas of best practice and process improvements.

Minimum Requirements/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 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 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. 
• Ability to be an effective member of multi-disciplinary project teams and build relationships with scientific leaders, KOLs, academic partners, CROs and health authorities.
• 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. 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.

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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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