VP Medical, Clinical, and Regulatory Affairs
Director Medical, Clinical, and Regulatory Affairs - Butterfly Network
Butterfly Network’s mission is to democratize healthcare by making medical imaging accessible to everyone around the world. We are reinventing medical imaging and championing a new era of healthcare by creating the first ever pocket-sized, whole-body ultrasound device - the Butterfly iQ. This breakthrough technology has reduced the cost of the traditional ultrasound system by miniaturizing it onto a single semiconductor silicon chip.
Since inception, Butterfly has raised over $375 million. The Butterfly iQ has received CE Mark and FDA clearance, and is being sold in hospitals and clinics around the globe.
Joining Butterfly Network is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
We are looking for a Vice President of Medical, Clinical, and Regulatory Affairs to help us further our mission to democratize healthcare and support our strong growth. In this newly created role, this person will lead our clinical development and health economics programs and proactively engage with key opinion leaders to facilitate informative scientific discussions and input. This leader will work closely with our Chief Medical Officer to develop and scale our clinical strategy and will lead all regulatory efforts.
As part of our team, your core responsibilities will be:
- Oversee the clinical team and all clinical operations; including design and delivery of our clinical program
- Build a best in class clinical research and health economics team to prove our value proposition to users, customers, clients and regulators
- Develop, implement, and manage the team’s global regulatory strategy consistent with Butterfly’s overall strategy, both as a business and in partnership with our clients’ specific asset/product needs, both for hardware, software and AI applications
Design and plan clinical studies and research for regulatory and commercial purposes
- Oversee patient recruitment and clinical trial study completion to drive efficiency, timeliness, and relevance of clinical data
- Meet with KOLs, study Principal Investigators, and other key external constituents on a routine basis as deemed appropriate to gather information on clinical study performance, strategy, voice of customer, etc
Lead the Regulatory team and establish a robust regulatory science organization, with processes and procedures on behalf of all regulatory business needs within Butterfly
Ensure Butterfly’s adherence to all local and national regulatory reporting obligations and requirements in all relevant geographies and support the processes, oversight, quality assurance and audit functions or interfaces to properly manage these responsibilities, in partnership with Butterfly’s Quality organization
Support commercial and business development due diligence activities and education as required
Experience working across multiple stakeholders to build and support clinical education
- You have an advanced clinical degree ( PhD, MD)
- You have had direct managerial experience for at least 6 years
- You have enterprise level experience (i.e. experience not confined to product teams) preferably with direct functional accountabilities, however cross-functional experiences may suffice
- Fluent knowledge and successful execution of all stages of medical device (including ideally software) regulations and compliance and documentation.
- You have strong organizational, management, matrixed leadership, teamwork, and interpersonal skills, as well as a passion for leading and developing teams
- You have outstanding communication skills (written and verbal, both formal and informal)
- You have the ability to manage multiple projects simultaneously in a fast-paced environment
- You are effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams
You Deeply Identify with Core Butterfly Network Values:
- Efficient & Speedy - you get work done in a fraction of the time as industry peers
- Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
- Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
- Team Oriented - you celebrate and take joy in the success of others on the team
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks.
- 401k plan - we facilitate your retirement goals
- Beautiful office overlooking the Flatiron building in NYC
- The opportunity to build a revolutionary healthcare product and save millions of lives!
Butterfly network does not accept agency resumes.
Butterfly Network Inc. is an E-Verify Company and is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.