Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we’re growing fast and we’re as focused and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

The Digital Strategy Head for Oncology Regulatory Science and Strategy (ORSS) is responsible for overseeing all digital and technical aspects of the ORSS function.  The Digital Strategy Head will lead contributions towards developing the digital ORSS strategic roadmap, and where required  provide ORSS input to the enterprise wide regulatory strategic roadmap. You will lead the documentation of an end to end information model for Regulatory Information, lead  implementation of digitisation of the end to end business process for ORSS. You’ll also identify and implement a governance framework for information in ORSS in collaboration with Regulatory Excellence and other Regulatory Groups.

You will lead identification of use cases where AI machine learning algorithms can be applied on oncology data and oversee implementation of the use cases along with AstraZeneca technology and development groups. You’ll work with the ORSS Leadership Team (LT) and the pertinent members of the ORD (Oncology Research Development ) LT to grow the function through the use of technological resources. Using an active and practical approach, you will liaise with all key employees and global regulatory services and solutions in Regulatory Excellence and AZ IT, Clinical,  Informatics groups and data scientists to ensure that the function’s IT and informatics goals and efforts are aligned with the company’s strategic goals established in the company’s strategic plan.

Typical Accountabilities, what you will be doing:

•             The Digital Strategy  Head  would lead contributions towards developing the digital ORSS strategic roadmap, and where required  provide ORSS input to the enterprise wide regulatory strategic roadmap

•             Leads identification of use cases where AI machine learning algorithms can be applied and oversee implementation of the use cases along with AstraZeneca technology and development groups.

•             Own and run ORSS relationship with related technology development groups at AstraZeneca for ORSS specific solutions.

•             Leading ORSS support in evaluation of new technologies, data assets and other innovative efforts both within and outside of AstraZeneca. These evaluations are in collaboration with Regulatory Excellence and AstraZeneca technical and data specialists.

•             Lead  identification of key data sources of interest to ORSS and maintain a roadmap of future data assets that ORSS should Findable accessible interoperable and reusable available to its community. This includes assets in the clinical data, and regulatory data and associated late stage development data.

•             Support the definition of new governance guidance and internal policies as needed, in conjunction with Regulatory Excellence and other relevant ORSS partners. Support its implementation by technology peers and colleagues

•             Lead ORSS contributions and input to the dialogue with Regulatory agencies on Information and data exchange

•             Engage in medium-term and long-term planning  along with data and technology teams and in defining areas of focus.

•             Closely align and partner with key internal stakeholder groups  (i.e. Regulatory Excellence, RIA and CVRM Reg TAs, Clinical,  AI and Data group; Enterprise and Data Analytics; AZ2025). Serve as ORSS liaison to those groups and initiatives and ensure alignment with enterprise strategy

•             Contribute to ensuring regulatory compliance and Licence to operate across markets in close collaboration with Regulatory Excellence

•             Drive innovative strategy for emerging technologies pertaining to regulatory informatics

•             Accountable for identification data sources for regulatory specific information (drug labels, approval summaries, FDA/EMA workshop presentations etc.)

•             Attend and present at digital and technology conferences where regulatory authorities express their opinions on emerging technologies and develop strategic plans to incorporate emerging technologies in the overall strategic framework of ORSS

•             Act as an advisor to the ORSS cross-functional teams, supporting our scientific community

•             Storytelling through our digital technology, simplifying our content and helping us to explain it

Education, Qualifications, Skills and Experience:

Essential:

•             Degree in Life Sciences, Pharmacy, or Medicine or another relevant business discipline

•             Previous life science or healthcare experience

•             Life Sciences technology consulting scientific background, a depth and breadth of analysing of data

•             Large transformation and change management and program experience

•             Effective project and resource management; proven ability to handle a broad range of customers and team members

•             Biopharmaceutical industry experience with demonstrated ability to leverage data and analytics for decision making

•             Strong customer-focused approach and track record of working in complex matrix organizations

•             Deep understanding of analytics landscape in the Pharma/biotech industry

•             Understanding of Clinical, Regulatory & Patient Safety  information value chain

•             Ability to disseminating complex information to a wide

Desirable:

•    MBA with consulting expertise 

•     Previously worked with big data with an ability to derive data insights

•     Knowledge of Python or R or related programming languages

•     Experience with Waterfall, Agile and Hybrid project management methodologies
 

Location: Cambridge or Macclesfield, UK, Gaithersburg, US or Warsaw, Poland

Next steps, if the role looks suitable for you please apply!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.