This is what you will do:
Do you have expertise in AI, Software as a Medical Device, Radiology, Electronic Health Records, Digital Business Development, and passion for bringing AI medical devices to the practice of medicine? Would you like to apply your expertise to impact the diagnostics odyssey of rare disease patients in a company that follows the science and turns ideas into life changing medicines? Are you ready to do the work of your life to change the lives of rare disease patients in the age of AI? Brilliant! We have a seat at the table, and we hope it's yours.
The Diagnostic Center of Excellence is an enterprise expert function residing within Alexion R&D (Research & Development) responsible for developing and commercializing diagnostics for rare disorders to change the lives of rare patients and those who work tirelessly to help them. AI Diagnostics is a strategic pillar within the Diagnostics CoE (Center of Excellence) focusing on Alexion strategic priority to develop Artificial Intelligence (AI) Software as a Medical Devices (SaMD).
You will be responsible for:
- Serve as subject matter expert on AI software as medical device development and commercialization.
- Serve as subject matter expert of the global diagnostic landscape for diseases Alexion is developing therapies and strategies where AI diagnostics can shorten the diagnostic odyssey.
- Develop requirements specifications for AI diagnostics and partner with tech industry, healthcare providers, medical device industry, startups, professional societies, and healthcare providers to develop and bring to market AI Software and Medical Devices.
- Drive internal stakeholder management and governance processes and external digital business development for collaboration (request for proposal (RFP), agreement development, negotiations, alliance management etc.).
- Drive multi-year collaborations to completion with agility.
You will need to have:
- Experience in a pharmaceutical/MedTech/HealthTech company developing AI products under GxP (minimum 2+ years).
- PhD or equivalent with demonstrated experience in biomedical engineering, computer science or a related field.
- Demonstrated track record of medical research for AI products and/or medical device development.
- Demonstrated expertise of AI SaMD regulatory, standards (DICOM, HL7 etc.) and AI, medical device and anti-bribery and corruption laws.
- Exceptional delivery mindset: demonstrated ability to drive innovation proactively, at a fast pace in a bureaucratic environment by tactically breaking deadlocks and making and owning decisions.
- Demonstrated experience leading multidisciplinary teams (regulatory, quality, business development, procurement, business - R&D, medical affairs, commercial etc.) by influence, setting direction, providing oversight and guidance, without direct reporting lines.
- Ability to do the work themselves as needed, self-starter.
- The duties of this role are 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:
- Experience in regulatory submissions and AI SaMD commercialization. Ideally on a global scale.
- Strong knowledge and experience of the drug discovery and development process
- Rare disease experience is not required but is a plus.
In-person statement for 4 days in the office:
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.
Date Posted
04-Jun-2024
Closing Date
24-Jun-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.
What We Do
Our mission is to transform the lives of people living with rare diseases and devastating conditions through the development and delivery of innovative medicines, as well as through supportive technologies and healthcare services.
By continuing to deepen our understanding of rare disease, which began with our pioneering work in complement biology, we are able to innovate and evolve into new areas where there is great unmet need and opportunity to help patients and families fully live their best lives.
Our culture is rooted in integrity, inclusiveness, and our dedication to joining and supporting the communities in which we live and work. We invest in and value people who believe in the importance of our purpose and understand what it takes to deliver on it. Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world.
At Alexion, our passion drives us to continuously innovate and create meaningful value in all we do. In doing so, we change lives for the better – ours, people living with rare diseases, and the communities we serve. Every day.
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