Associate Director, Product Owner

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 authorisation and employment eligibility verification requirements.