SENIOR DIRECTOR, DEVICE DEVELOPMENT

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 overse Device/Combination Product Project development to support Alexion Portfolio including Leading project, supporting documentation and related activitiesYou will be responsible for:Lead Device/Combination product project to support molecules developed by Alexion with cross functional Team. 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 supportPerform 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 experienceExperience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.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 roadmapsWorking 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 baseStrong 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 presentationsDeep 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).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 an 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-year experience (6-10 year for PhD) in medical device developmentDate Posted24-Sep-2024Closing Date31-Oct-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Boston - MAType: Full time