Strategic Data Manager RWD (AI)

The Real-World Science Department is anchored within the AI and Analytics area, which is part of the Data Science Division. In Real-World Science we provide insights and evidence based on advanced analysis of Real World Data (RWD) to support decision making and evidence generation throughout product development. By leveraging a blend of scientific, problem-solving, and quantitative skills, we provide superior data insights that empower us to further develop and deliver life-changing products. We work in multidisciplinary teams with strong collaboration across all areas of the organization and engage in external collaborations to ensure access to cutting edge research and methods.
The PoThis position will focus on developing processes and governance for innovative research projects that leverage RWD for AI & Analytics (AIA) teams within Data Science. They will develop completely new processes such as bringing in RWD for hybrid trials, digital twins, and more.  This position will focus on broader projects that are not in our current ways of working and work closely with existing teams to implement the processes that they develop.
This position reports to the Associate Director of RWD Assets.  Internal relationships include data scientists, epidemiologists, leaders and specialists across AIA, clinical trial teams, legal, compliance, IT and others across US, UK, and Denmark primarily, with additional geographies to be included in the future. External relationships include commercial and academic collaboration partners.Individual contributor – no direct or indirect reports.

Essential Functions:

• Working with data scientists /AIA team leads to collect requirements, consolidate cross-departmental needs and develop processes for their innovative projects leveraging RW
• Working with data scientists /AIA team leads to collect requirements, consolidate cross-departmental needs and develop processes for their innovative projects leveraging RW
• Generate guidance on various tracks to help facilitate and execute RWD and novel AIA projects in clinical development space
• Support contracting, procurement, compliance, statement of work and legal review with the respective experts from Novo Nordisk
• Working closely with Real-World Data Stewards to implement new processes and move forward projects leveraging RWD
• Coordinate with legal and compliance to understand what is in scope and out of scope for new projects and how to move them forward; and to comply with regulations
• Drive forward projects such as:
• 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
• Generate guidance on various tracks to help facilitate and execute RWD and novel AIA projects in clinical development space
• Support contracting, procurement, compliance, statement of work and legal review with the respective experts from Novo Nordisk
• Working closely with Real-World Data Stewards to implement new processes and move forward projects leveraging RWD
• Coordinate with legal and compliance to understand what is in scope and out of scope for new projects and how to move them forward; and to comply with regulations
• Drive forward projects such as: 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

Requirements

• Master’s Degree required with 5+ years of relevant experience; additional relevant advanced degrees my substitute for some experience as deemed appropriate.

Relevant experience includes:
• Experience in pharmaceutical industry (experience within a pharmaceutical or biotech company preferred)
• Working with legal and compliance in the context of RWD and/or clinical data  
• Project management across diverse areas of an organization that required change management
• Education in or 2+ years working as a data scientist highly preferred
• Working in the digital health space; working knowledge of Software as a medical device (SaMD) highly desired