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.
JOB SUMMARY
The Biosample Management (BSM) Leader will establish and oversee the Biosample Management process across Precision Medicine (PrM). The successful candidate will have a positive attitude with a passion for accountability and an eagerness to get work done. They will manage and work closely with Biosample Operations (BSO), Biosample operation of Good Clinical Practice laboratoy (GCP SciOps) and other biosample-related departments/groups such as Scientific Operations (SciOps), project management, quantitative clinical pharmacology (QCP), translational science (TS), and companion diagnostics (CDx) to integrate these existing activities into an efficient, holistic BSM process across activities within PrM. 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.
The BSM leader will ensure strong relationships with external parties, including analytical laboratories, central laboratories, long-term bio-repositoryies 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, GCP SciOps and other biosample-related departments/groups 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 team in establishing processes and best practices in alignment with regulatory requirements and industry trends.
Responsibilities
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
Work Experience
This Job Profile is a summary of the position's responsibilities and required qualifications at the point in time at which it was created. However, responsibilities at a growing organization such as ours are dynamic. This Job Profile may not accurately reflect future responsibilities and accountabilities associated with this position. This description is based on management’s assessment of the requirements and functions of the job of the date this description was prepared. It is a general guideline for managers and colleagues, but it does not purport to be an exhaustive list of all the elements of the job. Management reserves the right on a temporary or indefinite basis to change or adjust job requirements in order to meet business, scheduling and staffing needs.
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.