Head of R&D Data Governance
Daiichi Sankyo, Inc.

Albuquerque, New Mexico

Posted in Pharmaceuticals


Job Info


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. 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

This role has the flexibility to function on a remote basis for those outside the region OR corporate Basking Ridge NJ site based.

The Head of R&D Data Quality & Governance will lead the R&D Data Governance framework governing the interrelated capabilities of People, Data Standards, Processes, Data Quality and Enabling Technologies, and embedding a Data Governance program and competency by providing leadership, management, coaching, vision and execution necessary to ensure that R&D has an effective Data Governance practice in alignment with Daiichi Sankyo global standards. It will provide subject-matter expertise in the management of risk associated with data mis-use, adulteration, loss and inaccuracies. This role will rely on emerging data management skills, including data quality, metadata management, data change management and data sourcing. This role leads an emerging data governance team that is responsible for access/use/control of R&D organizational data in compliance with established data governance processes.


This person will define and oversee a model of data stewardship, to ensure data is of high quality and fit for purpose for critical R&D data assets. They will provide process, solutions to enable monitoring of the timeliness, accuracy, completeness and consistency of data across systems along with driving the accountability within business line functions through communications & targeted interventions with Functional Leadership and Associates at all levels.


Responsibilities

  • Develop & implement Data Governance framework & methodologies including strategy, approach, timelines, objectives & success criterias. Communicate information governance policies and their importance / relevance to key constituents, information stewards, system owners,stakeholders and data consumers
  • Assess current state of data fidelity, data security, privacy and data retention within the enterprise. Build AS IS and TO BE data governance state. Build and Execute plan to enforce data governance framework..
    Chairs a Data Governance governing body/council comprised of data owners, data stewards, and data architects to drive operational efficiency and manage data during its entire lifecycle, ensure target goals for data fidelity improvement and adherence with all types of data governance policies are met within proposed timelines.

    Reports to Executive Sponsors all performance and issue-related items.
  • Lead and mentor the Data Governance matrix team members (data owners, data stewards, data managers, data architects, data consumers, etc.) globally. Ensure DG team members are trained on DG methodologies, frameworks, technologies and processes.
  • Collaborates with domain experts in privacy, security, and compliance to ensure that the data platforms uphold privacy, security, and compliance requirements.
    Collaborates with IT and Data Architects in providing requirements for enabling technologies to support data governance processes, data standards and mastering, data quality and data management.

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 in Computer Science or a related field from an accredited college or university. required or
  • Master's Degree in Computer Science or a related field from an accredited college or university. required

Experience Qualifications

  • Familiarity with and understanding of key industry best practices as well as legislative, regulatory and industry artifacts/frameworks such as the following:
    o 21 CRF § 11: Electronic Records, Electronic Signatures
    o 21 CFR § 312.32: IND Safety Reports.
    o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection (January 2009)
    o FDA Guidance for Industry and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012)
    o Japan Ministry of Health, Labor and Welfare artifacts
    o Security and protection of organizational data assets
    o Access Control leveraging administrative controls of data access rights for cross-functional users
    o Data Enrichment services, including data standardization, natural language processing
    o Data Quality operations that standardize data definitions, implements quality rules, and aligns with quality management system
    preferred
  • Understanding of principles, practices, theories, and/or methodologies associated with the professional disciplines, as outlined in Data Management Body of Knowledge (DMBOK2) preferred
  • 10 or More Years of experience (w/BS) or 10+ (w/MS) in life sciences, pharma or informatics industry working with Clinical Trials, Genomics / Bio Markers, Discovery , Real World data etc. preferred
  • 4 or More Years as Data Governance Lead role in a formal Data Governance program. preferred
  • 4 or More Years hands on experience with contemporary data governance platforms/technologies like Collibra, Informatica DG, Alation, Erwin DG, DATUM, Infogix etc. preferred
  • 4 or More Years of experience with Data Quality, Master Data Management, Reference Data Management, Data Retention & Archival , Data Access Control & Data Security software. 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.

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.



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