Description

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:

DSS Director Data Engineering System and Technology (m/f/x)

The Position:

Actively contribute to define and execute the vision and strategy for global DSS technology, covering the full data life-cycle and value creation. Lead DSS system life-cycle activities, ensuring compliance with regulations and industry standards, and oversee data applications and visualizations. Partner with stakeholders to execute technology initiatives and consult on technology aspects, including vendor management. Manage team performance and development, utilizing expertise in clinical technology solutions and process excellence.

  • DSS Technology Responsibilities
    • Actively contributes in developing DSS strategy for cross-functional technology infrastructure. Ensure appropriate and proactive networking with key stakeholders, understand incoming business needs, implement DSS systems vision and strategy.
    • Contributes to the development and implementation of global DSS vision and strategy. Identifies innovation, technology, Data Governance/Stewardship, and business needs to proactively meet customer expectations, improve harmonization, and efficiency for cost savings and accelerated worldwide product development and access.
    • May represent DSS in company initiatives, committees, and working groups related to technology solutions, data governance, and associated processes.
    • Administrative responsibilities for recruiting, retaining, coaching, developing, and managing individual contributors within the DSS-DEN system function.
    • Author or initiate writing of global system-related standard operating procedures. Oversee and ensure compliance with system-related standard procedures and processes.
    • Will lead functional and/or multidisciplinary teams working on projects and initiatives.
    • The position holder will have strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures.
  • Portfolio Lead for Data Engineering
    • Contributes to the development and is responsible for execution of DSS systems strategy to exceed/achieve quality, time, and cost objectives.
    • Plans/directs the selection and use of DSS systems for outsourced and/or insourced activities.
    • Provides oversight for system use by internal resources, CROs, and other third-party vendors to ensure compliance with external/internal standards, GxPs, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
    • Functions as DSS systems escalation point for all studies within the assigned program(s).
    • Proactively identifies and manages risks at the functional level and/or for assigned programs, and/or initiatives.
    • Partners with internal and external stakeholders to optimize DSS technology, processes, and standards.
    • Participates in audits and inspections to represent line function expertise and ensures inspection readiness related to systems and Data Governance.
    • Supports standards management.
  • External Vendor Management
    • Responsible for all the Vendors providing technology solutions directly to DSS.
    • Manage higher-level negotiation and provides oversight of budget, resources, and timelines with technology providers for multiple projects across the department and ensures timely delivery of high-quality deliverables at reasonable cost.
    • Supports vendor qualification and oversight for CROs, technology, and data-related vendors in DSS functional or drug program level outsourcing.
  • DSS Department Innovation and Operational Excellence
    • Lead global DSS technology and Data Governance innovation for activities outside the Regulatory perimeter.
    • Contribute to developing and implementing global vision and strategy to leverage systems and data governance innovation and operational excellence. Identifies opportunities, creates and leverages networks with internal/external stakeholders to drive systems, processes, and tools based on emerging trends, technology, and best practices.
    • Leads global/regional implementation of improvements and makes recommendations for regional/global implementation.
    • Leads global DSS initiatives to improve the harmonization and efficiency of processes by coordinating the work of an assigned team of experts.
    • Actively contributes to the review of best practices within the function.
    • Coordinates with key stakeholders regionally/globally to optimize cross-functional interfaces and collaboration.
    • Utilizes systems expertise to promote best practices throughout the Drug Development lifecycle.
    • Develops and maintains peer relationships with thought leaders in technology and Data Governance and related areas.

  • Minimum 10 years in clinical data and statistical sciences and related systems experience in pharmaceutical industry, medical device, or similar environment (e.g., CRO).
  • Extended knowledge in cross-functional clinical technology solutions (incl. Metadata Repositories, EDC/eCOA, Statistical Computing Environments, Clinical Data Repositories, etc.) and related process excellence, industry guidances (e.g., GxP, Data Governance, GAMP), regulations (e.g., GDPR), and standards (e.g., CDISC).
  • Minimum 10 years experience in clinical technology projects and Business Process Management.
  • Strong background in leading technology transformations, agile project management, and vendor management.
  • Minimum 7 years Line Management Experience.
  • MSc or BSc in Life Sciences or related field.
  • Experience in Oncology or Cardiovascular Therapeutic Area in conducting clinical programs and studies.
  • Experience in technology requirements for late-phase projects.
  • Extensive knowledge in cross-functional clinical technology solutions and related process excellence, industry guidances (e.g., GxP, Data Governance, GAMP), regulations (e.g., GDPR), and standards (e.g., CDISC).
  • Project Management qualification preferred.

  • Excellent Benefits
  • Work-Life Balance
  • Growth and Development
  • Health and Wellbeing Support