Software as a Medical Device (SaMD) Expert
Our entire business is transforming at pace. We’re on a journey to become a data-led enterprise from IT through to R&D. We’ve come so far, but in many ways we’re just getting started…
There’s no better place, or time, to join. We’re investing like never before in our people, in growth, and in new techniques and technologies. There are opportunities at every turn, with a variety and breadth that is uncommon to find.
Scientists at AstraZeneca are working every day to turn science fiction into science fact. Our dream - to develop innovative, targeted medicines for every patient that needs them - and to match those treatments to patients most likely to benefit from them – is now becoming a reality. This approach, known as Precision Medicine, is based on those individual characteristics that make some patients respond to treatment better than others. We use this knowledge to develop diagnostic tests that doctors can use to help prescribe the best treatment for each patient. Indeed, it’s now become common practice for patients with cancer to be offered such diagnostic tests before their treatment plan is agreed
The Diagnostic Science group within Precision Medicine transform data and innovative technologies into future diagnostic options to match patients’ needs. The development of diagnostic algorithms is one of our focus areas.
We are currently seeking a Software as a Medical Device Expert (SaMD) to join the group.
You will be responsible for guiding Diagnostic Software as a Medical Device (SaMD) projects through all stages of development, including prototyping, development, deployment, validation and regulatory submission for launch in key markets. The role will provide a combination of data science, software development and regulatory input to Precision Medicine projects where SaMD is a component in patient segmentation. As part of a cross-functional project team, you will develop options for development and regulatory interactions, liaise with software development teams and vendors and provide input to study protocols and regulatory documents. This will be to enable timely and successful SaMD deployment to maximise patient access to our medicines.
Typical Accountabilities, what you will be doing:
- You will establish and champion diagnostic SaMD competency in Precision Medicine
- Develop regulatory path options and SaMD product requirements to enable preferred diagnostic strategy
- You’ll provide input to clinical study protocols and regulatory documents
- Scout and evaluate and liaise with potential external partners for SaMD development
- You will guide early R&D teams responsible for SaMD prototyping
- Provide leadership and guidance to software development teams and vendors operating in CFR 21-part 11 compliant environment
Education, Qualifications, Skills and Experience:
- PhD or equivalent experience in life science and/or AI/data science, software development, medical devices
- Experience in at least three of the following fields: pharmaceutical development, diagnostic development, machine learning, software development and deployment, regulatory
- Understanding of drug and diagnostic development processes
- Proven record of leading projects in a matrix environment and collaborating in cross-functional teams
- Demonstrated leadership in developing and deploying Software as a Medical Device products
- Demonstrated experience in deploying large scale web or mobile apps
- Experience in Oncology/Cardiovascular/Respiratory therapy areas
- Rich network in data science, software, diagnostic industries
Role can be considered at career levels E - G depending on the suitability and experience of the successful candidate.
Location: Gaithersburg or New York, US, Cambridge, UK or Gothenburg or Stockholm, Sweden.
Closing Date: 29th February 2020
Next steps, if you feel you are suitable for the role please apply.
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 authorisation and employment eligibility verification requirements.