Manager, Biosample Operations

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

The Biosample Operations Manager, Biosample Management is responsible for supporting the oversight of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near real-time tracking of samples, ensuring that samples are collected, used, stored or disposed of appropriately per the associated study Informed Consent Forms (ICFs). The role is expected to work in close collaboration with several cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, Central & Specialty Laboratories and CROs.

Responsibilities

Chain of Custody

• Responsible for performing near real-time biosample tracking for the assigned studies in close collaboration with the QCP, Clinical Biomarker Team, Companion Diagnostics, the Clinical Study Teams, Central & Specialty Laboratories, and CROs
• Oversee CRO partner sample management activities per study level including sample tracking, site escalations, query resolution, and missing samples
• Support the planning and coordination of activities required to manage the lifecycle of biosamples (e.g., collection, shipping, processing, analysis, data delivery and cleaning, and final sample disposition)
• Support implementation, maintenance, and use of internal and external tracking tools including excel based sample tracking tools. May be responsible for running the outputs as needed from the tools to support tracking
• Responsible for management of biosample shipments (e.g. working with cross-functional stakeholders for sample selection, managing shipment timeline, reconciling outbound and inbound sample shipment manifests,and tracking ad hoc shipments in trackers)
• Review the CRO partner Sample Management Plan, to document cross-functional agreements on the tracking, lifecycle and reconciliation plan for each sample type.
• Responsible for providing timely updates and coordination of sample movements needed for analysis or long-term storage to key stakeholders
• Support the management of the lifecycle of bio samples to ensure they are used and/or stored appropriately per the associated ICFs
• Support ongoing inventory reviews and work with the appropriate stakeholders to obtain approvals for disposal/transfer of samples in long-term storage facilities
• Support resolution of biosample related data reconciliation and sample related risks/issues at sites, Central labs or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and QCP/CDx/Clinical Biomarkers
• Support clinical study teams and functional working groups on technical and operational sample-related questions and/or escalations. Triage requests to the appropriate SME and follow up on the requests/escalation as needed.

Process Documentation and Improvement

• Support review of study documents that pertain to biosample collection, handling, and storage including but not limited to Informed Consent Forms, laboratory manuals, Statements of Work including database specification documents, flow charts and Sample Management Plans
• Participate in Case Report Form (CRF) development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes.
• Support resolution of informed consent and IRB/EC questions related to biosamples in collaboration with relevant stakeholders
• Support development and update of global DS policies, guidance documents, Standard Operating Procedures (SOPs), or Standard Operating Instructions (SOIs) to support biosample management activities
• Ensure appropriate performance and quality targets are established (via metrics and KPIs) for biosample related vendors.
• Lead and/or support identification of trends in biosample queries and lead/support implementation of improvements to mitigate recurring queries
• Support activities including but not limited to conduct of gap & impact assessment and developing project scope and project plans.
• Work cross-functionally with stakeholders to identify when a process revision is required.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education

• Bachelor's degree in Life Sciences field required

Work Experience

• Minimum of 4 years relevant experience required
• 2 or more years of bio-sample handling experience required
• Working knowledge of ICH/GCP and regulatory guidelines/directives preferred
• Working knowledge of CLIA/CAP regulations and GLP guidelines preferred
• Basic knowledge of clinical trial design; understanding of the overall drug development process preferred
• Excellent organizational and communication skills required
• Advanced Excel knowledge preferred
• Ability to manage multiple competing priorities and meet timelines required
• Proven networking skills and ability to share knowledge and experience amongst colleagues preferred

Travel: Ability to travel up to 20%

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.