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

　　Establish and continuously optimize overall BSM processes across PrM. Support development of a strategy, including QCP, TS and CDx, and process to construct and execute plan document such as Pharmacokinetics (PK), Anti-Drug Antibody (ADA) and biomarker analysis plans, which aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents.

　　With other PrM leadership, develop the best BSM plan/structure to fit each clinical development project. Choose BSM paths for project development including partnerships and external collaborations. Ensure an effective BSM plan, resourcing, and execution across all clinical studies and projects.

　　Interact with external parties to identify operational issues and define directions for resolution. Oversee internal and external functions that monitor progress of execution, including CROs, and resolve issues.

　　Manage direct reports and staff. Ensure good working relationships and development opportunities. Plan headcount needs to match the development portfolio.

　　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

　　PharmD, PhD, or MD is preferred

　　Master's Degree required required

　　Work Experience

　　10 or more years experience in pharmaceutical or biotechnology drug development required

　　Knowledge of ICH/GCP and regulatory guidelines/directives required

　　Knowledge of CLIA/CAP regulations and GLP guidelines preferred

　　3 or more years managing direct reports, preferably in a bio-sample management group required

　　Ability to multi-task across projects and functions managerial experience preferred

　　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.

　　At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.