Job Title:              R&D Digital – Clinical Data Collection Lead

Locations:          New York

Salary:                  Competitive with excellent benefits.                      

In 2016, we started our transformation journey in our research & development organisation, launching a new operating model to optimize our drug development activities, which is already achieving significant benefits, including simpler, streamlined ways of working and productivity improvements.

Now we are further accelerating our transformation efforts to ensure we demonstrate the best in new technology and leading-edge capabilities to keep us at the forefront of future drug development.

Our Future Reimagined (OFR) is reimagining how we work to position AstraZeneca as an industry leader, making the development & delivery of new medicines easier. We’re doing this by harnessing the latest innovations enabled by digital, data & analytics and working with our people to design and build the technology and working practices.

AstraZeneca’s Research & Development digital organisation develops digital solutions to support our development and commercial drug portfolios. These digital solutions encompass connected drug delivery devices, monitoring devices and sensors coupled with medical device software to:

• Improve clinical development, through optimising data collection and improving communications between AZ, HCP and patients
• Provide enriched data sets to support regulatory submissions, and differentiated labelling
• Optimise real world medication use by patients and deliver digital interventions to improve clinical outcomes
• As part of the program the team will provide digital solutions across all AZ clinical trials and develop and execute AZ’s Digital strategy. We have secured significant investment in a digital platform to enable rapid development and global deployment of bespoke digital solutions for all clinical trials. This solution is built on a standardized set of modules to enable identification of patients, recruitment, ongoing engagement and retention, support to sites and collection of data directly from patients.

You will work in collaboration with the R&D Digital Platform lead, the Device lead, Implementation leads, and Digital therapy area leads to set, implement and deliver the enterprise remote data collection strategy across CVRM, Respiratory and Oncology therapy areas.  This includes mapping and influencing the external environment in the related area

Responsibilities:

You will:

• Work closely with the Implementation lead to define and execute the data collection strategy using devices & sensors
• Working closely with the TA leads and Product Owners to design the strategy and deliver required capabilities to be used by Product Owners to collect and analyse data in clinical studies and Digital therapeutics.
• Actively map and search the external environment to accurately describe the subject matter area – in particular focussing on regulatory and payer environment and acceptance of direct data capture
• Externally influence and be a recognised leader in the subject matter.
• Participate in cross-functional project working (or sub) teams tasked with delivery of the digital plans as a subject matter expert
• Develop and manage relationships with external technology and service providers
• Help build a learning organisation: ensure that any learning associated with the programs is shared within the Digital Organisation

Essential Requirements:

• Bachelors Degree in a scientific field
• Meaningful relevant experience in R&D and strong knowledge of Drug Development processes.
• Knowledge of the use of medical sensors in digital health.
• Excellent knowledge of regulatory endpoint validation.
• Well-developed Project management skills, including managing vendors, budgets, timelines and risks.
• Ability to work collaboratively in a cross functional setting with internal as well as external partners.
• Ability to challenge the status quo, take ownership and holds self and others accountable
• Good communication skills, with the ability to deal with ambiguity and create clarity.
• Passion for Customers, representing the needs of multiple customers in decision making.

Desirable:

• Experience of developing products to support patients in AZ’s therapy areas
• Device, software development and / or clinical project management
• Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation
• Ability to work globally including international travel

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.