Senior Director, Device Development

At AstraZeneca, we win through the science, it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees' activities and the roles of our teams, partners, and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Introduction to Role

Are you ready to lead the charge in device development for Alexion products? As the Senior Director, Device Development, you'll be at the forefront of continuous product improvement within the Global Product Development function. This pivotal role involves leading device development activities and being responsible for Device/Combination Product Project development to support the Alexion Portfolio. You'll lead projects, support documentation, and drive related activities that make a difference!

Accountabilities

• Lead Device/Combination product projects to support molecules developed by Alexion with cross-functional teams.
• Drive activities related to the project, including design control activities, design verification, and modernization to support coordinated design control activities from clinical development through registration and commercial support.
• Perform deep reviews of the projects with engineers to ensure technical and timing robustness.
• Support Due Diligence for new acquisitions or new device technologies.
• Ensure all designs function as required and align with the company's quality assurance requirements as well as applicable regulatory requirements.

Essential Skills/Experience

• Bachelor's or Master's in Engineering (Mechanical, Electrical Engineering, Biomedical or Chemical), plus 10-15 years of experience in medical device development.
• Minimum of 8 years of direct multi-functional program management experience in the development and commercialization of device branded products.
• Mandatory experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.
• Mandatory working experience in phase-based design control activities with coordinated risk management work and human factors/usability engineering studies, from research through registration, launch, and life cycle management.
• Demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.
• Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps.
• Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.
• Effective communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Proficient in authoring internal reports, project summaries, and internal/external presentations.
• Deep knowledge of the performance, safety, and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g., ISO 11608 series, ISO 14971, IEC 60601 series, IEC 62304, FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements, and related FDA guidance).

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 four 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.

At AstraZeneca, you'll find an environment where diversity is celebrated and innovation thrives. Our patient-driven culture is energizing and kind, fostering connections that lead to groundbreaking ideas impacting patients' lives. We value inclusion and different perspectives, ensuring that life-changing ideas can emerge from anywhere. Our commitment to kindness is as strong as our ambition to succeed for those in need. We take pride in giving back to our communities.

Ready to make a difference? Apply now and join us on this exciting journey!