Senior Manager – AI (Artificial Intelligence) Diagnostics
Alexion Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- 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.
- 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.
- 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.