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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.
Summary
The BioSample Management (BSM) Leader will establish and oversee the BioSample Management process across Precision Medicine (PrM). The successful candidate with have a positive attitude with a passion for accountability and an eagerness to get work done. They will manage and work closely with the leaders of BioSample Operations (BSO) and Scientific Operations (SciOps) to integrate these existing activities into an efficient, holistical BSM process across activities within PrM, which includes quantitative clinical pharmacology (QCP), translational science (TS), and companion diagnostics (CDx).
The BSM leader will also ensure effective coordination of BSM with other R&D functions such as Clinical Operations, Biostatistics/Data Management, Outsourcing/Procurement, etc. In coordination with the BSO and SciOps leaders, the BSM leader will ensure strong relationships with external parties, including analytical laboratories, central laboratories, long-term biorepository(ies) and CROs. This work entails shifting the organization from an outsource model with indirect oversight of vendors to direct management of these relationships. An important aspect of this work is to establish processes with these parties that reflects the Daiichi Sankyo way of working, which is then applied uniformly across our rapidly expanding portfolio of clinical studies. In addition, the BSM leader will support integration of BioSample-related data across studies and analytical labs. These data include sample collection information, analytical results, and inventory status. This work will ensure proper and efficient data curation, harmonization, and annotation consistently across data sources for incorporation into data repositories for bioinformatic analyses.
The successful candidate will bring innovative ideas to enhance BioSample management, inventory tracking and handling of associated data. The leader will establish the BSM group’s vision, strategy, and annual goals. They will also establish clear roles and responsibilities for BSO, Sci/Ops, and other Bio sample-related departments to lead consistent execution of all BioSample related activities globally, including collection, handling, storage, disposal, transfers, and project management for analyses. The BSM leader will ensure compliance with all regulations and SOPs. As processes evolve, the BSM leader will be accountable for updates to applicable SOPs. This position is part of the operational side of PrM and develops strategies to improve cross-departmental alliances to ensure seamless operations. The Senior Director is responsible for providing expertise and guidance to the leaders of PrM and Clinical Operations to lead and support the BSO and Sci/Ops teams in establishing processes and best practices in alignment with regulatory requirements and industry trends.
Responsibilities:
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
Experience Qualifications:
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.
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