Associate Director, 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 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 Associate Director, Bio-Sample Operations Management will partner with cross-functional teams, in particular, the Clinical Biomarker and Companion Diagnostics Teams, to coordinate and oversee biomarker and PK sample management activities in clinical trials and to facilitate management of the bio-samples tracked via the GlobalCODE system and other tools/systems.

Responsibilities:

• Chain of Custody
  • Collaborate with the Clinical Biomarker Team, the clinical study teams and CROs to perform biomarker and real-time testing specimen tracking for the assigned studies.
  • 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.
  • Support individual clinical study teams and biomarker sub-teams as needed to provide information on technical and operational sample-related matters.
  • 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.
  • Liaise with Data Management, Clinical Operations and Clinical Biomarker Team to resolve biomarker related data reconciliation, and sample related issues at sites or analysis labs.

• Facilitate Global CODE Operation
  • Communicate with various stakeholders to identify new studies to load in Global CODE and provide guidance on the budget proposal workflow.
  • Facilitate and support data loading from various sources (including EDC, IRT, Veeva, Central Labs, Specialty Labs, etc.) into Global CODE.
  • Coordinate the transfer of study protocols, central lab manuals and ICF templates to GSS for loading and codification in Global CODE. Identify ICF templates that require translation and work with the clinical study teams to facilitate translation.
  • Assist in the verification of data accuracy within Global CODE, including specimen identifiers and metadata, and ICF-associated permissions.
  • Monitor for protocol amendments and ICF revisions that may impact the information in Global CODE and serve as a communication gateway to GSS on those changes.
  • Work closely with the Global CODE vendor (GSS; a Covance company) to ensure communication about timelines and deliverables is maintained.

• Bio-sample Operations Documents
  • Review documents that pertain to bio-sample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals.
  • Work with Clinical Biomarker Team Procurement to review contracts for vendors responsible for sample processing, PGx analysis and storage.
  • Work closely with the Clinical Biomarker Team and the clinical study teams to address informed consent and IRB/EC questions related to bio-samples.
  • As appropriate, assist in the development of global DS policies, guidance documents, SOPs, or SOIs to support bio-sample management activities.

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 preferred.
• Master's Degree with 5 years' experience preferred.
• PharmD with 2 years' experience preferred or
• PhD with 2 years' experience preferred.

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.