This is what you will do: This position will serve the role of Senior Director for Device Development for Alexion products including continuous product improvement within Global Product Development function of Alexion. The role will manage device development activities. The role will lead and oversee Device/Combination Product Project development to support Alexion Portfolio including leading projects, supporting documentation, and related activities.
You will be responsible for: Lead Device/Combination product project to support molecules developed by Alexion with cross-functional teams.Drive activities related to the project including design control activities, design verification, and industrialization to support integrated 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 acquisition or new device technologies.Ensure all designs function as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.You will need to have: Mandatory experience in drug-device combination product development and commercialization of a minimum of 15-20 years of experience.Experience in commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentations.Minimum of 8 years of direct cross-functional program management experience in the development and commercialization of device branded products.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.Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch, and life cycle management.Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.Strong communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Proficient in writing 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 / ISO 13485 quality system requirements, and related FDA guidance).The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have: Bachelor's, Master's, or PhD Degree in Engineering (Electrical Engineering, Biomedical, Mechanical, or Chemical), plus 10-15 years of experience (6-10 years for PhD) in medical device development.
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.
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