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Manager, Scientific Operations

2 months ago


Basking Ridge, United States Daiichi Sankyo Full time

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 16,000 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 purpose of the Manager Scientific Operations is to provide project management and day-to-day operational support to multiple functional teams within the Precision Medicine group. This position shall oversee the operational side of the department and develop strategies to improve cross departmental alliances to ensure seamless PrM operations.

Responsibilities

Collaborates with Outsourcing & Procurement, Finance, Purchasing and vendors to execute contracts and amendments, resolve invoice queries, generate budget estimations, execute CDAs and support PO tracking activities.Performs program and project management to independently organize, formulate and execute timelines for PrM projects including key study milestones, submission related activities, interaction and alignment with cross departmental and external stakeholders to meet critical deadlines.Provides project management support to functional sub-teams. Manages memberships, facilitates meetings to assemble study deliverables at multiple decision points in the Global Drug Development Process and authors meeting summary across multiple program and project sub teams.Performs document management activities to support submissions and TMF management - Drives review and approval activities in partnership with Medical Writing and Publishing teams, in addition to managing PrM documents on shared drive to support submissions. In addition, facilitates submission related coordination with Reg Ops. Also, responsible for maintaining study TMF for designated projects on behalf of the PrM department.Identifies opportunities and recommends strategies for scientific operations process improvement that promote efficient collaboration of PrM with other internal and external collaborating partnersProvides Scientific Operational Support for the specific functions within PrM including study management support across multiple programs, project management to establish and implement bioanalysis deliverable timelines, oversight of vendor logistical activities and vendor access to DS systemsManages clinical study sample tracking, reporting and summarizing processes: Establishes procedures for each study and manages multiple stakeholders to maintain ongoing clinical sample result tracking and prompt safety follow ups for the bioanalytical group.Responsible for functional management of bio sample management and reconciliation 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, ideally in science, engineering, or management, with relevant professional experience or equivalent is required.Advanced degree is preferred.

Experience Qualifications

4+ years of experience in pharma industry and at least 5 years’ drug development project management experience or equivalent preferred.Industry experience: direct, global pharmaceutical or drug development experience required.Familiarity with GDP, clinical development, TMF management and submissions vault, Gantt charts and Microsoft Project required.Ability to multi-task across projects and functions desirable.Managerial experience desired but not required.


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.