Who We Are
BlackThorn Therapeutics, Inc., is a clinical-stage neurobehavioral health company pioneering the next generation of artificial intelligence technologies to advance its pipeline of targeted therapeutics for treating brain disorders. The company has engineered PathFinder™, a cloud-based computational psychiatry and data platform, to enable the collection, integration and analysis of multimodal data at great speed and scale. BlackThorn applies its data-driven approaches to create an understanding of the core underlying pathophysiology of neurobehavioral disorders and uses these insights to generate objective neuromarkers, which support drug target identification, patient stratification and objective clinical trial endpoints. By identifying more homogenous patient subgroups who share underlying neurobiology, BlackThorn aims to direct its drug candidates to neurobiologically-defined patient populations most likely to respond. BlackThorn is headquartered in San Francisco, California.
The Position
At Blackthorn Therapeutics, we’re looking for a creative Software Validation Specialist who will own and lead the information technology standard operating procedures (SOPs) and the software verification and validation activities for our software applications, used by subjects participating in clinical trials. A successful candidate will have a passion for implementing, maintaining, and enforcing high software quality standard from product conception to launch. In this role you will:
- Work with Quality Assurance to standardize our software validation process
- Create and own software validation document deliverables
- Develop and execute software test plans
- Own traceability of requirements to test cases
- Own configuration management activities
- Perform regression testing with every new software releases and/or configuration change and update validation documents as required
- Work with product management and engineering from bug identification through resolution
- Own and manage the continuous integration pipelines and test automation suites
- Represent Software Quality Assurance on design and test considerations through the software development lifecycle
- Collaborate with the engineering teams to develop unit tests
- Own the creation, maintenance, and adherence verification for IT SOPs
Who You Are
- Have at least four years of direct experience working on regulated diagnostic and/or research software products.
- Have experience creating and maintaining Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Protocols, and Summary Reports
- Managed the IT Change Control process
- Have experience representing Software Quality Assurance on Agile teams
- Have experience being a process owner for Software Quality Assurance organizations
- Have a strong track record leading and executing medical device and/or clinical research software verification and validation campaigns
- Have at least four years of technical writing experience
- Have a keen ability to test and provide UX suggestions with the end user in mind, focusing on simplicity and outcomes.
- Hold a BS/BA degree in computer science, science, or engineering disciplines