Research Senior Scientist

$133,000 - $133,000/Yr

Takeda Pharmaceutical Company - Boston, MA

Full-time - Senior

Remote - Boston, MA

Chemical Manufacturing

About the position

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 Research Senior Scientist 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 work to advance the mission of BST and its contributions to the clinical program lifecycle. You will support the planning and coordination of clinical sample activities required to manage the lifecycle of biospecimen samples, ensuring standardization and harmonization of end-to-end biospecimen activities across clinical trials. Your role will involve developing robust processes to facilitate the planning, coordination, and oversight of all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens, collaborating with various stakeholders to resolve sample and data reconciliation issues, and ensuring adherence to quality and regulatory standards. In this position, you will also be responsible for developing and maintaining metrics for specialty lab vendor management, supporting audit and inspection preparations, and participating in initiatives to create efficiencies and drive simplification in the execution of clinical testing paradigms. Your contributions will be vital in ensuring the delivery of high-quality bioanalytical and biomarker data to clinical programs, ultimately supporting Takeda's mission to transform patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

Responsibilities

• Support the planning and coordination of clinical sample activities required to manage the lifecycle of biospecimen samples.
• Ensure standardization and harmonization of end-to-end biospecimen activities across clinical trials.
• Develop robust processes to facilitate the planning, coordination, and oversight of all logistical activities required to manage the lifecycle of bioanalytical and biomarker specimens.
• Help develop best practices for resolution of biosample related data reconciliation and sample related activities in collaboration with relevant stakeholders.
• Utilize sample and data management automated tools to help define the process for data reconciliation of clinical biomarker samples and datasets.
• Collaborate with Clinical Operations, clinical CRO, specialty and central laboratories to resolve sample and data reconciliation issues in a timely manner.
• 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.
• Responsible for developing and maintaining metrics for specialty lab vendor management at the partnership level.
• Help 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.
• Participate in initiatives to create efficiencies and drive simplification in the execution of clinical testing paradigms.

Requirements

• 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.
• Excellent written, organizational, and interpersonal communications skills.
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
• 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.

Nice-to-haves

• Knowledge of regulations from other regions (e.g., China and Brazil) is a plus.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires