Associate Director, Biorepository Lead

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.

The Associate Director, Biorepository Lead will be responsible for understanding and performing functions related to the lifecycle of specimens, including patient consenting and sample collection, storage, usage and destruction. Additionally, this individual will support day-to-day operations and work closely with biorepository vendors which store biological specimens collected through clinical trials for exploratory research.

Responsibilities:

• Oversee all functions related to sample registration, processing, and shipment.
• Manage the lifecycle of biomarker samples to ensure that samples are used and/or stored appropriately per the associated ICFs.
• Manage sample inventories for samples transferred to long-term storage facilities.
• Support ongoing inventory reviews and work with the appropriate stakeholders to obtain approvals for disposal/transfer of samples in long-term storage facilities.
• Provide input and guidance on human biological requirements to science functions.
• Provide input to clinical study teams and biomarker sub-teams on technical and operational sample-related matters.
• Work closely with Clinical Biomarker Team, Companion Diagnostics Team and Clinical Operations, to provide timely updates and coordinate sample movements needed for analysis or long-term storage.
• Manage relationships with Bio-Sample storage vendors (as appropriate), including assisting with contracts and vendor oversight.
• Maintain long term storage budget and forecast for long term storage budget for clinical trials.
• Serve as a central point of contact for requests for shipments for future use of Bio-Samples and ensure approval is obtained from appropriate function.
• Maintain vendor sample database and sample inventory.
• Support the biorepository in resolving issues to ensure continuous improvement, including changes in procedures based on new policies and updates to operations based on organizational needs.
• Ensure teams follows DSI biorepository processes to deliver effective support to the science functions while maintaining compliance with human biological sample standards and external legislation.
• Lead development of new approaches to improve the global biorepository processes and will lead implementation of new ways of working.
• Develop and maintain Standard Operating Procedures (SOPs), project definitions, and other necessary forms and documents related to biorepository operations.
• Ensure work is performed in accordance with global standards, SOPs, Good Clinical Practice and legal requirements.
• Keep up to date on recent developments in the biorepository field.
• Lead and champion new innovations or approach to improve global biorepository processes, including automation and process modification.

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)

• Bachelor's Degree in a Life Sciences field and a minimum of 8 years' experience in pharmaceutical or biotechnology drug development or
• Master's Degree with 5 years' experience or
• PharmD with 2 years' experience or
• PhD with 2 years' experience

Experience Qualifications:

• 1 or more years of bio-sample handling experience preferred.
• Working knowledge of ICH/GCP and regulatory guidelines/directives preferred.
• Working knowledge of CLIA/CAP regulations and GLP guidelines preferred.
• Experience in bio-sample management at a pharmaceutical company or CRO preferred.

Travel: Ability to travel up to 20% In-house office position that may require occasional travel (global).

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.