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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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 Director, Biosample Operations (BSO) Management will be the Head of the Biosample Operations Management team and establish the group’s vision, strategy, and annual goals. The Director will oversee Biosample Operations Management globally for in-scope studies.

The Biosample Operations remit involves the following key areas -

• Define the strategy and global processes for end-to-end biosample tracking, monitoring, and ensuring the appropriate use and storage of biosamples based on the associated informed consent information.
• Establish clear roles and responsibilities for BSO managers to allow for a predictable and consistent execution of global-sample-related activities that include collection, handling, storage, disposal, and transfers.
• Identify and use appropriate sample tracking data, systems, and tools to support BSO process execution including a centralized sample management platform.
• Serve as the primary point of contact for the coordination of biosample-related activities including those with central labs. Coordinate interactions with various stakeholders including but not limited to Precision Medicine, Study Management and Alliance Management to identify, resolve any biosample-related issues and/or risks and ensure actionable information is communicated in a timely manner to key stakeholders.

As part of line management responsibility, the Director is responsible to provide expertise and guidance to the BSO team members. The Director will lead and support the BSO team in establishing processes and best practices in alignment with regulatory requirements and industry trends.

Responsibilities:

1 Define Strategy and Execute on Bio sample Operations related Processes

• Communicate with global stakeholders in Precision Medicine and clinical operations to provide a streamlined, global strategy for chain of custody operations
• Support Global Precision Medicine team members on clinical study teams to perform biomarker and real-time testing specimen tracking for the in-scope studies
• Provide strategy on and oversee the biosample group’s management of biomarker samples over their lifecycle to ensure that samples are tracked, and used and/or stored appropriately per the associated ICFs
• Oversee the coordination of sample movements needed for analysis or long-term storage
• Oversee biosample group’s support of individual clinical study teams and Precision Medicine sub-teams as needed to provide information on technical and operational sample-related matters
• Provide targeted operational support to Precision Medicine to facilitate external translational research and specimen reconciliation
• Work collaboratively with the study teams and Alliance Management to address central lab biosample-related issues and risks.
• Collaborate with data management, clinical operations, and Precision Medicine to facilitate biomarker related data reconciliation, and address sample related issues at sites or analysis labs
• Facilitate GlobalCODE operation, including but not limited to the following:
  • Monitor the verification of data accuracy within GlobalCODE, including specimen identifiers and metadata, and ICF-associated permissions
  • Work closely with the GlobalCODE vendor (GSS) to ensure communication about data loading is maintained
  • Manage the collaboration with IT to facilitate data loading into GlobalCODE from various sources (including EDC, IRT, Veeva, Central Labs, Specialty Labs, etc.)

2 Bio-Sample Operations related Process Documentation & Improvement

• Lead and/or assist in the development of global DS policies, guidance documents, SOPs, or SOIs to support biosample management activities. Ensures all relevant documents are current and up to date.
• Provide input to processes and documents that pertain to biosample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals
• Collaborate with Procurement to review contracts for vendors responsible for sample processing and storage
• Manage the communication with Precision Medicine and the clinical study teams to address informed consent and IRB/EC questions related to biosamples
• Address informed consent and IRB/IEC questions related to biosamples from Precision Medicine and Clinical Study Teams
• Establish KPIs and metrics to monitor and evaluate Biosample Operations processes
• Charter, champion and lead process improvement initiatives

3 People and Resource Management

• This position requires the supervision of direct reports
• In addition to providing training and direction for daily activities in support of goals, this job will conduct performance evaluations against goals for their direct reports.
• In addition, this job will coach and guide their functional and/or direct reports in support of their development needs, and provide real-time feedback on job performance
• Develop plan for resourcing of activities within remit/scope. Ensure appropriate resources (employee and/or contractor-based) are available to support current and future clinical programs and studies.

Qualifications:

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
 

Education

Bachelor’s Degree in a Life Sciences field and a minimum of 10 years’ experience in pharmaceutical or biotechnology drug development (Master’s Degree with 8 years’ experience; or PhD/PharmD with 5 years’ experience)

Experience

• Knowledge of ICH/GCP and regulatory guidelines/directives
• Knowledge of CLIA/CAP regulations and GLP guidelines
• A minimum of 2 + years managing direct reports, preferably in a bio-sample operations group
• A minimum of 5 years of bio-sample handling experience or adjacent process areas

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.

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.