Global Development Operations (GDO) is the bridge that turns great science into great medicine. We provide clinical trial operations services to the divisional development teams, taking the compounds developed by our colleagues and test those compounds in clinical trials.
We have more than 5,000 colleagues working across more than 60 countries, working in specialized core functions for end-to-end trial operations management:
- Trial Management
- Trial Monitoring
- Data Operations
- Regulatory Writing and Submissions (RWS)
- Strategic Planning and Feasibility
And dedicated capabilities to drive continuous improvement:
- Transformative Business Operations
- Risk Management
- External Development Operations (EDO) for vendor management
- Strategy and Integration
- Clinical Innovation and Technology
These focus areas, combined with our use of advanced technology and data analytics allow us to make informed decisions, potentially resulting in new, life-changing therapies for patients globally.
The Novartis Group’s Chief Medical Office and Patient Safety organization is an integrated team which provides Novartis-wide oversight and governance of patient focused activities including Patient Safety, Pharmacovigilance, Device-vigilance as well as Ethical, Regulatory and Reputational issues. We support our company mission by further strengthening our focus on patients and providing patient-centric solutions and outcomes by:
- Establishing a single Chief Medical Office for Novartis for all patient related policy and standards
- Creating one single Safety/pharmacovigilance organization across all divisions and one harmonized Product Stewardship team
- Integrating all country level Pharmacovigilance and Device vigilance into a single organization
- Implementing and deploying the Novartis Patient Declaration across the Group
4 years with Novartis. From an intern to HR Analyst and Patient Safety Specialist. Novartis offers us the flexibility to drive our own career. There are many growth opportunities here, and innovation and thinking-outside-the-box mindset is actively encouraged, even when it comes to your career development.
Giselle,Patient Safety Specialist
We in the Technical Research & Development (TRD) team are responsible for developing innovative technical product designs and robust, scalable manufacturing processes.
We are responsible for the manufacture and supply of all pre-clinical and clinical study materials across all stages of clinical and pharmaceutical development. We add value by working with and enabling a broad spectrum of cross-divisional partners, including early Research teams (see Research) late phase Development and registration teams, our commercial manufacturing teams, (see Technical Operations) and our Generics development teams (Sandoz.com).
Given this huge breadth of areas covered by TRD, we as associates benefit from one of the strongest possible learning environments and professional, career development opportunities.
We have an impact on a variety of other Novartis functions too. As a team of 2500 associates we work across 4 continents and 8 countries, developing practically the entire Novartis portfolio, across all Disease areas, including cutting edge Cell and Gene therapies.
We in the Portfolio Strategy and Management team provide innovative methods and systems that enable informed decision making across Development in order to advance the Science of Medicine and the Science of Operations. Additionally we help to identify and lead strategic initiatives and programs to drive innovation and new capabilities across the Development team.
The newly created Data & Digital team within GDD aims to use the power of data and digital to enhance the value of our innovative and impactful medicines. For instance, by reducing the time it takes to develop medicines, and improving our processes, or to bring down costs which can be reinvested back into R&D.
A growing number of data science and digital technology solutions are already in play aiming to:
- Leverage all available data to generate insights about diseases, patients and treatments
- Deploy technologies to improve the patient experiences, help trial recruitment and retention and enhance the benefit of our drugs
- Embed tools e.g. predictive analytics to improve our end-to-end trial processes
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Clinical Development & Analytics (CD&A) is an integrated global line function delivering clinical, biostatistical, advanced analytical and functional excellence in integrated drug development.
We are organized around the following 4 key areas:
- Therapeutic Areas (TAs) across the Development Units and Sandoz Biopharmaceuticals
- Analytics function comprised of the Biostatistics and Pharmacometrics groups
- China Development and Japan Clinical Development
- Central Team comprised of Clinical Sciences, Pediatric Centre of Excellent, PRO Centre of Excellence and Strategy & Operations groups