Why choose AstraZeneca Spain?
AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.
We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Diverse collaborators
This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.
Cutting-edge innovators
When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.
Resilient trailblazers
Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.
Agile movers
Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.
Responsibilities
We are seeking a highly skilled Product Owner to lead the development, validation, and deployment of AI/ML-based software, with a primary focus on under Sponsor Responsibilities or Investigational Use Only (IUO) applications. This includes implementing algorithmic software for pre-screening, screening, and monitoring activities in AstraZeneca-sponsored trials. A critical aspect of this role is ensuring that all software development and deployment activities comply with Good Practices (GxP) standards in the context of clinical trials. Additionally, as a secondary focus, the role encompasses the development and integration of Software as a Medical Device (SaMD), particularly for diagnostic and screening algorithms and biomarkers within the context of standard care.
The Product Owner will also be responsible for managing third-party vendors acting as legal manufacturers, ensuring alignment with regulatory requirements and company objectives, including working with AZ procurement in RFI/RFP process.
Accountabilities
Product Ownership & Strategy:
- Own the SaMD AI/ML product roadmap, ensuring alignment with business objectives, regulatory requirements, and AstraZeneca market needs.
- Define and prioritize the product backlog, ensuring the highest-value features are delivered in an agile or incremental development environment.
- Work closely with AI/ML Scientists and Engineers, Software Developers, QA teams, and UX designers to ensure high-quality software development and validation.
- Ensure compliance with ISO 13485, IEC 62304, FDA regulatory frameworks, based on the product regulatory assessment and product intended use.
Regulatory Compliance & Validation:
- Oversee the Development Life Cycle and the SaMD validation process, ensuring compliance with regulatory standards, driving the successful delivery of solutions to a validated and packaged component state, suitable for third-party engagement and utilization.
- Define and support risk management activities, including hazard analysis, failure mode effects analysis and cybersecurity risk assessments, in alignment with the different disciplines and SMEs.
- Coordinate with Quality Assurance and Regulatory teams to ensure proper documentation and submission for regulatory approvals, where required.
Stakeholder & Third-Party Management:
- Act as the key liaison between business owners, development teams, and external partners (including legal manufacturers and notified bodies).
- Collaborate with third-party legal manufacturers to ensure successful device registration, post-market surveillance, and compliance.
Agile & Cross-Functional Collaboration:
- Lead agile ceremonies (e.g., sprint planning, backlog grooming, retrospectives) and drive continuous improvement.
- Collaborate with AstraZeneca TA and Functions sponsors and stakeholders to define product positioning, market strategy, and value proposition.
- Support the development of go-to-market strategies and work with marketing and sales teams to ensure successful product launch.
- Utilize strong communication, strategic planning, and organizational skills to manage deadlines, resources, and project priorities effectively.
- Work closely with software development and management teams to integrate best practices in software development processes.
Essential Skills/Experience
- College/university degree.
- 5+ years of experience in a Product Owner, Product Manager, or similar role within SaMD, Digital Health, or AI/ML-driven medical technologies.
- Strong knowledge of Software as a Medical Device (SaMD) regulations, including ISO 13485 or IEC 62304.
- Experience in AI/ML-based medical software development, including data-driven algorithms and validation approaches.
- Hands-on experience with Agile or Incremental development methodologies (Scrum, Kanban).
- Ability to translate business needs into technical requirements and communicate effectively across cross-functional teams.
- Ability to engage effectively with stakeholders across multiple disciplines.
- Demonstrated experience working in a matrix organizational structure.
- Strong compliance orientation, with a keen eye for detail.
- Excellent communication, planning, and organizational skills.
Desirable Skills/Experience
- Familiarity with software development and management processes.
- Track record of collaborating successfully with AI research/engineering teams to deliver complex AI solutions.
- Experience managing third-party legal manufacturers and external development vendors.
- Familiarity with FDA pre-submission processes, submissions, and MDR CE-marking pathways.
- Background in software engineering, AI/ML development, or digital health product management.
- Experience working in cross-functional teams spanning R&D, Regulatory, Clinical, and Commercial functions.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech. We are forever expanding our horizons. By sharing and increasing our knowledge we are empowered to be the best we can be and accelerate progress.
Ready to make a difference? Apply now!
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.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.
An award-winning company
We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.
Inclusive environment
Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.
Work-life balance
Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.
Sustainability initiatives
We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.
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