Director Biosample Operations
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: May 14, 2022
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Job Description:
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 ProcessesCommunicate with global stakeholders in
Precision Medicine and clinical operations to provide a
streamlined, global strategy for chain of custody operationsSupport
Global Precision Medicine team members on clinical study teams to
perform biomarker and real-time testing specimen tracking for the
in-scope studiesProvide 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 ICFsOversee the coordination of
sample movements needed for analysis or long-term storageOversee
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 mattersProvide targeted
operational support to Precision Medicine to facilitate external
translational research and specimen reconciliationWork
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 labsFacilitate
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 permissionsWork closely with the GlobalCODE vendor
(GSS) to ensure communication about data loading is
maintainedManage 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 & ImprovementLead 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 manualsCollaborate with Procurement to review contracts for
vendors responsible for sample processing and storageManage the
communication with Precision Medicine and the clinical study teams
to address informed consent and IRB/EC questions related to
biosamplesAddress informed consent and IRB/IEC questions related to
biosamples from Precision Medicine and Clinical Study
TeamsEstablish KPIs and metrics to monitor and evaluate Biosample
Operations processesCharter, champion and lead process improvement
initiatives3 People and Resource ManagementThis position requires
the supervision of direct reportsIn 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 performanceDevelop 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:EducationBachelor'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)ExperienceKnowledge of ICH/GCP and regulatory
guidelines/directivesKnowledge of CLIA/CAP regulations and GLP
guidelinesA minimum of 2 + years managing direct reports,
preferably in a bio-sample operations groupA minimum of 5 years of
bio-sample handling experience or adjacent process areasDaiichi
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.
Keywords: Daiichi Sankyo, Inc., Newark , Director Biosample Operations, Executive , Basking Ridge, New Jersey
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