About the Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
The Strategic Real World Data Manager will be an integral part of Real-World Science and partly responsible for the data strategy and data foundation in Data Science. In collaboration with stakeholders across Data Science but also legal, procurement and IT, the candidate will be responsible for strategically identifying relevant clinical data sources, assessing quality and bringing the data in-house for the data scientists to generate valuable insights from the data. This position will also focus on developing new processes and governance for additional stakeholders such as Research & Early Development to leverage real world data (RWD). This position will balance between executing on existing processes and strategies, and on developing and driving forward new projects that are not in our current ways of working.
Relationships
This position reports to the Associate Director of RWD Assets. Internal relationships include data scientists, epidemiologists, leaders and specialists across Data Science, clinical trial teams, legal, compliance, IT and others across US, UK, Denmark and other geographies. External relationships include commercial and academic collaboration partners.
Individual contributor - no direct or indirect reports.
Essential Functions
- Leads collaborations across Data Science and the broader organization to identify data gaps and needs for projects leveraging RWD
- Identifies relevant sources of data that can close these data gaps, conduct quality assessment and contract negotiation
- Communicates clearly with team and stakeholders regarding status, processes, and expectations
- Collaborates with legal, finance, procurement to execute on data contracts
- Collaborates with data privacy and IT to ensure data are governed appropriately
- Creates and maintains a relevant internal stakeholder network as well as an external vendor network
- Maintains critical process documentation in support of processes
- Ensures documentation is in accordance with requirements and addresses discrepancies as required
- Generates guidance on various tracks to help facilitate and execute novel RWD projects across product lifecycle
- Collaborate with scientific teams to drive forward novel projects when RWD is required such as, but not limited to,
- Software as a medical device
- Sourcing data from KOLs in a non-interventional study to be used for a CT
- Digital twins studies
- Hybrid clinical trial designs
- Other types of non-interventional clinical studies leveraging both retrospective and prospective data
- Projects involving commercial vendors and academic collaborators
Physical Requirements
This position can be based out of Novo Nordisk's offices in either Plainsboro, NJ or Lexington, MA. Approximately 10% overnight travel (including international travel).
Qualifications
- Education Level:
- Minimum: Bachelor's Degree from an accredited academic institution (or an equivalency document) and at least 8 years relevant experience; or Master's Degree from an accredited academic institution (or an equivalency document) and at least 5 years relevant experience required; or PhD from an accredited academic institution (or an equivalency document) and 3 years of relevant experience
- Experience Level:
- Minimum: 3 years of relevant work experience depending on degree level
- Relevant experience includes:
- Understanding of data contracting, data privacy, data sourcing/scouting, data science
- Ability to network internally and advocate for role of department in RWD governance
- Project management across diverse areas of an organization that required change management
- Ability to communicate clearly, transparently, and escalate concerns when appropriate
- Working knowledge of pharmaceutical product development
- General knowledge of clinical data and data science, commercially available data
- Experience can be a combination of paid and academic experience
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Top Skills
What We Do
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.
We are powered by technology. Our Global Research Technologies, Medical Devices as a software, and Data Science teams are on the cutting edge of developing and supporting our life-saving medications.
Why Work With Us
Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.