AI-driven Personalized Medicine for Cancer Care
Do you want to be part of a global innovative precision oncology company that is improving the treatment of cancer using high-throughput biology and AI? ImpriMed is a dynamic startup launched by two Stanford Engineering PhDs to solve a major challenge faced by cancer care providers: complexity of cancer cell biology makes it difficult to find the most effective drug treatments for individual cancer patients. Our precision oncology platform provides a solution to this problem by profiling tumor cells and using AI to predict real-world clinical outcomes for different treatment options. Veterinary oncologists across the country are using our personalized outcome predictions to identify the most effective anticancer drugs for dogs with lymphoma and leukemia, and we are developing multiple services in human oncology. We are seeking a highly motivated, full-time Regulatory and Quality Affairs Manager to join our growing company. The role will be on-site at our headquarters in Mountain View, CA.
What you’ll do:
● Lead the work and communication required to obtain (1) the institutional accreditation and (2) approvals necessary for providing the precision medicine services
● Establish and manage QC&QA system for the commercialized services
● Support the work of the Korean office’s regulatory affairs (RA) team
● Communicate and cooperate with other teams on a regular basis to ensure quality and compliance of our research and services/products
● Review literature and announcements on an ongoing basis to maintain up-to-date knowledge of regulations and QC methods
● Define quarterly goals for the Regulatory and Quality Affairs Team and give presentations on the team’s progress
What you bring:
● MS in related field and at least 5 years of industry experience in the related position
● Experience with CLIA and/or GMP accreditation
● Experience with FDA and/or CE approval of medical services/products
● Possession of mathematical understanding and statistical knowledge regarding QC&QA of services and/or products
● Great writing and communication skills as well as managerial capabilities
● Passion for improving cancer treatment and eagerness to learn about clinical oncology
Great to have:
● Knowledge of HIPAA regulations
● Experience with cancer biology and/or artificial intelligence (AI)
● Experience working for CRO service providers
● Familiarity with Korean and/or European regulations regarding medical devices/services
