Manager, Scientific Operation
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: September 22, 2022
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 position of Manager
Scientific Operation, Precision Medicine (PrM) will be responsible
for managing a broad spectrum of PrM scientific operation
activities, including but not limited to contracting (budget
forecast, contract execution and invoice inquiry resolution, etc.),
project management and coordination of PrM sub-team activities and
regulatory submission deliverables, PrM regulatory documentation
management, liaison with internal and external partners and provide
project management and technically-associated logistic support for
clinical bioanalysis and biomarker tasks, identify scientific
operation improvement opportunities and drive cross-functional
process improvement initiatives. Responsibilities Collaborates with
Outsourcing, Finance, Purchasing and vendors to execute contracts
and amendments, resolve invoice queries, generate budget estimation
and support PO tracking activities.
Applies project management disciplines to organize, formulate and
execute timelines for PrM projects including regulatory submission
activities with high degree of independency. Facilitate and manage
interaction and alignment with cross departmental and external
stakeholders to accomplish critical PrM project goals.
Coordinate PrM project team/sub-team activities. Manages
memberships, facilitates meetings to assemble study deliverables at
multiple decision points in the Global Drug Development Process and
authors meeting summary across multiple PrM sub teams.
Performs document management support for PrM submission activities
- drives review and approval workflow in partnership with Medical
Writing and Publishing teams, manages PrM documents on shared drive
to support submissions.
Identifies opportunities and recommends strategies for scientific
operations process improvement that promote efficient collaboration
of PrM with other internal and external collaborating partners
Provides Scientific Operational Support for the Clinical
Bioanalysis and Translational Biomarker teams including study
management support across multiple programs. Applies project
management discipline to establish and implement clinical
bioanalysis timelines, oversight of vendor and project deliverables
and manages study logistics including sample tracking and
reconciliation. Act as the functional point contact for
coordinating vendor access requests to DS data and documentation
Leads the task of establishing study-specific work procedure for
reporting Anti-Drug Antibody data from bioanalytical lab to
clinical sites. Coordination and liaise multiple stakeholders to
maintain ongoing ADA sample results tracking, which is needed for
clinical study subject follow up visits decision making.
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 Science, engineering, or healthcare
administration preferred required and
Master's Degree preferred Experience Qualifications 4 or More Years
Working experience in pharma industry required and
1 or More Years Working experience in global drug development
1 or More Years Working experience in managing contracting
activities is strongly desired. preferred
1 or More Years Project management experience. Fluent use of
Microsoft Project to create Gantt charts is expected. preferred
1 or More Years Experience with GxP, TMF and Submission Vault
system preferred 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 , Manager, Scientific Operation, Executive , Basking Ridge, New Jersey
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