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Manager, Bioanalytical Operations

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.

Summary
The position of Manager Scientific Operation, Quantitative Clinical Pharmacology (QCP) will be responsible for managing a broad spectrum of QCP scientific operation activities, including but not limited to contracting (budget forecast, contract execution and invoice inquiry resolution, etc.), project management and coordination of QCP sub-team activities and regulatory submission deliverables, QCP regulatory documentation management, liaison with internal and external partners and provide project management and technically-associated logistic support for clinical bioanalysis 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 QCP 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 QCP project goals.
  • Coordinate QCP 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 QCP sub teams.
  • Performs document management support for QCP submission activities - drives review and approval workflow in partnership with Medical Writing and Publishing teams, manages QCP documents on shared drive to support submissions.
  • Identifies opportunities and recommends strategies for scientific operations process improvement that promote efficient collaboration of QCP with other internal and external collaborating partners.
  • Provides Scientific Operational Support for the Clinical Bioanalysis team 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 repository systems.
  • 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 organization preferred
  • 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.

Manager, Bioanalytical Operations

Bernards, NJ
Full Time

Published on 11/29/2021

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