Jobbeschreibung
With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
For our EU regional headquarters (position can also be based in an EU affiliate) we are seeking highly qualified candidates to fill the position:
Senior Manager (m/f/x) DSS DEN Systems and Technology
The Position:
Support the definition and execution of the DSS (Data and Statistical Sciences Centre for RWE and EG) systems and technology strategy, focusing on non-R&D patient-level data lifecycle management (including RWD), value creation, and ensuring system lifecycle compliance with regulations and standards. Collaborate with stakeholders and vendors to deliver business-aligned technology solutions and driving operational excellence in clinical technology.
- Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics
- Contribute to global DSS vision and strategy focusing on innovation, technology, data governance, harmonization, and cost efficiency.
- Represent DSS in company initiatives, committees, and working groups related to technology solutions and data governance.
- End-to-end system life-cycle management, including system administration and changes control
- Co-author and oversee compliance of global standard operating procedures (SOPs) for DSS systems and processes.
- Lead functional and multidisciplinary project teams to deliver DSS technology initiatives.
- Manage and optimize DSS systems usage by internal teams and external vendors, ensuring regulatory and policy compliance.
- Assist in vendor management including negotiations, budget monitoring, and vendor qualification for technology and data services.
- Drive innovation and operational excellence by identifying improvement opportunities and implementing best practices globally.
- Facilitate collaboration with regional and global stakeholders to promote harmonization and best practices throughout the drug development lifecycle.
- Strong expertise in cross-functional clinical technology solutions (e.g., Metadata Repositories, EDC/eCOA, Statistical Computing Environments, Clinical Data Repositories) and related industry guidances (GxP, Data Governance, GAMP), regulations (GDPR), and standards (CDISC).
- BSc or MSc (preferred) in Statistics, Computer Science, or related fields with several years of experience, including a few years in drug development or post-marketing within Clinical Research, Pharmaceutical, CRO, or Medical Device settings
- Profound knowledge in managing cloud-based clinical technology projects and Business Process Management, with solid background in technology transformations, agile project management, and vendor management.
- Preferable experience in line management and leadership roles.
- Therapeutic area experience in Oncology or Cardiovascular clinical programs, including late-phase project technology requirements.
- Project Management qualification is preferred; strong negotiation, remote collaboration, and communication skills in English.
- Deep understanding of Data Integrity, GDPR principles, and clinical research standards.
- Proven entrepreneurial mindset with leadership, proactive problem-solving abilities, and solid knowledge of clinical study design, conduct, and execution.
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support