USADirector of Clinical Affairs
1 мес. назад
USADirectorHybrid
clinical strategyteam managementbudget management
Lead clinical strategy and team for prenatal screening AI technology, managing studies, clinical priorities, and representing clinical affairs at executive level.
Обязанности
- You'll be the first Clinical hire in the US, leading a team covering both US & Europe. You'll directly report to the CEO and sit at the Excom. Your main missions are:
- Own clinical strategy end-to-end — translate Excom priorities into a roadmap of studies, claims, KOLs and communication, in partnership with the CSO; arbitrate clinical priorities across DS, RAQA, Marketing and Ops
- Manage and grow a 3-person clinical team, own the clinical budget, and represent Clinical Affairs at Excom
- Own the clinical case for FDA 510(k) and EU MDR submissions, with RAQA
- Drive KOL engagement and medical knowledge diffusion worldwide
- Build scalable, repeatable clinical operation
Условия
- ⚕️Health Insurance (Medical plan, vision, dental) - up to 30,000$ per year + FSA & HSA
- 👵 401(k) - up 4% of your salary matched
- ⛑️ Life Insurance - covering 2 times your salary, up to $200k
- 🐣 An attractive Parental Policy for primary and secondary caregivers
- 🏝️ 20 PTO + 1 week offered between Christmas and New Year
- 🖥️ Offices in Boston (HQ) & New York (incl. free breakfast, drinks & gym)
- ⏰ Flexible hours & remote policies
- 🚎 Commuter Benefits
- ✈️ One offsite per year in France & regular team building with US team
- 🚀 Ongoing trainings and continuous opportunities for professional growth and development, specifically unlimited access to coaching
- We move fast and aspire to be transparent over the process - our objective is that the process from the first chat to an offer is no longer than a month. We also aspire to give an answer to every application in a week - if you have not heard from us, please follow up at careers@.ai.
Другое
- Each year, 140M children are born. Birth defects affect 1 in 33 births in developed countries, and in 50% of cases, they are not detected during prenatal examinations. Prenatal medicine is particularly complex, and the scans impose heavy responsibilities on healthcare professionals. They can also be a source of stress for future parents.
- Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, uses artificial intelligence to improve prenatal screening and diagnosis. Based on patented algorithms and a proprietary expert database, aims to become the reference tool to help practitioners improve screening, reduce diagnostic errors, and optimize pregnant women’s medical path.
- 's mission is to improve women's and children's health by promoting access and quality of care through technological innovation, medical expertise, and collective intelligence.
- is a mission-driven company, so interest in our mission is critical. Other requirements are:
- 12+ years of experience in Clinical Affairs at a medical-device company, ideally in AI / SaMD; healthtech scale-up experience
- Strong technical/scientific background with ability to analyze/understand/assess technical, clinical, or scientific results
- Strong background in MFM / OBGYN / prenatal medicine (or credible transferability)
- Deep familiarity with clinical study design (validation, post-market, RWE), Good Clinical Practice, biostatistics fundamentals
- Proven experience partnering with RAQA on FDA 510(k) and EU MDR submissions; understands clinical-validation requirements for AI-based medical devices
- Strong experience managing team with both challenge & care
- Business acumen: comfortable arbitrating between science, product, GTM and regulatory priorities at Excom level
- Location: Ideally Boston, remote can be considered for the right candidate
- Salary: $180k - $200k + 10% bonus