Device & Sensor Expert - Digital Health R&D
Location: Cheshire East, Gaithersburg, Maryland
Job Type: Full time
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
The Digital Health R&D team has already delivered the first versions of bespoke digital solutions for global clinical trials. As part of the team, the Device Expert will further develop and execute AZ’s R&D Digital strategy by expediting patient identification and recruitment, engaging and retaining patients on trials, supporting sites with adopting digital solutions, and enabling direct data collection by patients.
The Device Expert will lead device and sensor scouting and selection for remote data collection by patients in all types of clinical trials together with the Unify Deployment team, Development Operations and other parts of AstraZeneca. You will then manage relationships with selected vendors and collaborate with Therapy Area Leads, Product Director/Owners and other Digital Health team members to prepare technologies for implementation in Unify and other digital health platforms. You will work in a team of Device Experts to jointly deliver a strategy for deployment of connected devices and curate a catalogue of validated and tested devices that can be readily adopted into clinical trials.
What you will do :
- Work closely with clinical teams, Digital Product Owners, the R&D Data Collection Lead and other internal experts, to define the strategy for execution of a digital measurement. Covering the operational deployment of digital technologies as well as data transfer, analysis, primary use, and future re-use
- Scout and evaluate suitable emerging technology to address gaps in the portfolio and deliver development programs with suitable partners
- Understand and apply external quality and regulatory standards relevant to Medical Devices, IVDs, and clinical trial data
- Collaborate with R&D Data Collection Lead and Patient Digital Platform IT team to ensure data from selected devices can be securely and reliably streamed into software platforms
- Lead specific device and measurement development activities such as risk assessments and Design Reviews
- Develop, qualify and maintain a portfolio of preferred devices and form close working relationships with external technology providers and collaborators
- Prepare device documentation to internal and external quality and regulatory guidelines (eg QSR/ISO/MDD/GMP/GLP/SHE requirements)
- Help build a learning organization: ensure that any relevant knowledge is shared across the Digital Organization
- Masters Degree in relevant scientific field such as engineering or life sciences disciplines
- Relevant experience in R&D and strong knowledge of the Drug Development process
- Knowledge in one or more of: Digital Health Technologies, Analytical Chemistry, Diagnostics, or sensing technologies
- Demonstrated Project Management skills, including managing vendors, budgets, timelines and risks
- Experience working collaboratively in a cross functional setting with internal and external partners
- Ability to challenge the status quo, take ownership and hold self and others accountable
- Good interpersonal skills and strong communicator, with the ability to deal with ambiguity and build clarity
- Passion for customers, representing the needs of multiple customers in decision-making.
- Advanced degree in a relevant scientific or technical field
- Experience working within a regulated software development lifecycle, ideally in Pharmaceutical, Biotechnology or Medical Technology environment
- Knowledge and application of international device standards for medical applications
- Awareness of the global regulatory landscape for digital health technologies in drug development
- Thrive in a fast-paced work environment, comfortable with complexity and uncertainty at times, dedication to excellence.
At AstraZeneca we’re dedicated to being an excellent Place to Work. Where you are empowered to push the boundaries of science and unleash your ambitious spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Competitive Salary and Benefits
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.