Clinical Data Domain Owner - Open to flexibility
Clinical Data Domain Owner - Open to flexibility
- Masters degree in scientific or mathematical background relevant to the domain in scope
- PhD in scientific, mathematical or computer science discipline relevant to the domain in scope
Why is using our clinical data important ? ...
One of GSK’s key items of value is its clinical trial data. However, we are not yet leveraging that data to its maximum potential. There is much more we could do to fully understand how past trials could be used to shape better future ones; to understand why some of our trials “fail”; to reduce the number of new trials or volume of assessments we ask of patients by questioning the data we already have; to look across disease areas or organisational boundaries to truly understand how we could target our medicines better. Finally, with recent initiatives like SHARE, how can we join our data with other companies, academic institutions, regulators, reimbursements agencies or payers to even more effectively answer all of the above and potentially gain insights that could game change R&D. The Data CoE is making tremendous progress building GSK’s new R&D Data Information Platform (RDIP), where over 4000 historical internal clinical trials will be converted into CDISC formatted data and loaded by summer 2017, alongside the loading of real world data and all our clinical operations information.
How can you help ? Summary of new role ...
To truly maximise the use of all our R&D data in the RDIP, data domains are being created that group like-minded data to facilitate the standardisation, integration and accessibility of that type of data. “Clinical” will be one such domain and we’re looking for an “Owner” that will be accountable to set-up, execute and maintain the domain strategy in this rapidly evolving area. Championing clinical data reuse, evaluating the needs of different communities of users and helping ensure their distinct needs are being met will be a key accountability in ensuring the domain is fit for purpose. In particular, encouraging and helping to establish use of the RDIP Clinical Data to effectively address the questions above and demonstrate value. This will include leading the development of access and security models, types of standards applied and versioning approach, helping to articulate potential use cases, as well as working with other domain owners to integrate data beyond a specific domain to prevent silos’ forming. In other words, this role will lead the development and execution of the strategy for what clinical data is in RDIP, and how is stored, maintained and accessed.
The role will report to Andrew Roddam (Head of Epidemiology & RWE, Qsci Management & Ops) with a dotted matrixed line to Steve Pyke (Domain sponsor) and senior leadership in the R&D Data CoE, along with other scientific platform organisations such as TSci, PTS and R&D IT to implement and demonstrate value of an integrated data strategy for the clinical domain. In this role it will also be important to build strong relationships and have credibility with key external opinion leaders as we help shape the space. Over time this role may grow direct line accountability for a small number of specialist data roles e.g. data curators.
This is an exciting domain where the demand from scientific users and senior executives in GSK is at its highest, and where interesting data challenges blend with huge opportunities to change our business through exploratory analytics. The successfully candidate will need to demonstrate strong leadership, clinical content expertise and change management skills to help GSK fully realise the potential of the data available.
- Responsible for developing and executing a data domain strategy, each domain being aligned to a business classification of data e.g. Clinical, Assay, Gene etc
- Leads a partnership with the R&D business lines, Data CoE, Domain sponsors and domain stakeholders (providers/consumers) to plan on a 1-5 year horizon including;
- Leading definition of Domain scope and population (data sources/types) ordering including oversight on the quality of the data, length back in history (scientific/business obsolescence), cost v’s curation, and prioritisation of emerging strategic and new sources internally and externally
- Leads the oversight on Domain sensitivities/security/access/legal considerations (eg asset divestment)
- Thought leadership on Domain standards, ontologies (both content and metadata) and the processes / resources for on-going curation
- Sets and delivers Domain integration requirements to the Platform team and business lines
- Co-owns Cross-Domain collaboration (how does this domain fit into the ecosystem), how data is shared across domains and how it is used longitudinally.
- Delivers, Manages and Leads the SME workflow to deliver data curation process including negotiation and change management of data creation with appropriate meta data and embedding of new processes to standardise data for example machine learning approaches
- Supports development of change management plans and leads execution of delivery within the R&D lines to identify and engage the right SMEs, securing the appropriate amount of time needed by the SMEs (i.e., ~20%)
- Supports the value creation (information as an asset), monitoring and reporting of this domain population and usage to others.
- Govern the access/control policy for the domain (facilitated by CoE framework)
- Provide/enforce guidance relative to GxP re-use of data
- Supports the Data CoE Innovation and Incubation group to define and prioritise use cases and delivery approaches
- Works alongside the Data CoE and R&D IT to ensure that the domain strategy and roadmap has a supported and sustainable IT roadmap, particularly with regard to lifecycle management of key sources on the R&D inventory
- Co-Leadership of Collaboration/Engagement with other domain owners
- Provides line management leadership of data experts where needed and leads relevant business lines with data stewardship plans and processes that drive re-use of data
This role operates across all/multiple R&D business lines, for example PCPS or PTS with support and guidance from the Data CoE. The impact of this role will span R&D and also set GSK up as having competitive advantage against external competitors.
The Domain strategy and delivery is supported directly by Patrick Vallance and the R&D exec and the domain owner will work with the R&D exec right through the lines to people creating and curating data
Thank you for your interest in this opportunity.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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