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Director, Clinical Research & Regulatory Affairs

$230k - $245k
Full-time

Butterfly Network

Director of Clinical Research Company Description Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging and sensing with its proprietary Ultrasound-on-Chip™ semiconductor technology and software solutions. Butterfly first proved its technology in the point-of-care ultrasound market – commercializing the world’s first single-probe, whole-body portable ultrasound device, which is now on its best-selling, third-generation: Butterfly iQ3™. The Company combines its advanced hardware with cloud software and AI, an enterprise workflow solution (Compass AI™) and other offerings to drive adoption of affordable, accessible ultrasound. Butterfly also enables third-party development of imaging AI apps through Butterfly Garden™, its software development kit and AI partnership initiative. In addition to its medical imaging products, Butterfly Embedded™ is the Company’s Ultrasound-on-Chip™ licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Through Butterfly Embedded™, partners can build and scale novel ultrasound applications powered by Butterfly’s proprietary semiconductor chip and software platform. Butterfly’s innovations have been recognized by Prix Galien USA, Fierce 50, TIME’s Best Inventions and Fast Company’s World Changing Ideas, among other achievements. We’re a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let’s build something extraordinary together! Job Description The Director of Clinical Research is responsible for leading and managing all aspects of clinical study activities at Butterfly Network. This role requires strategic planning and cross-functional collaboration to generate the clinical evidence needed to support product development and commercial growth. This position reports to the Chief Medical Officer and interacts with senior leadership, KOLs, clinical researchers, and partners. Key Responsibilities Clinical Study Management Lead all company-sponsored clinical studies in compliance with Good Clinical Practice (GCP), including developing Monitoring Plans and Data Management Plans. Design clinical study protocols and statistical plans in collaboration with cross-functional teams. Review and analyze clinical and scientific data to support pre-market and post-market product performance. Develop, revise, and implement SOPs for clinical trials and related activities. Investigator Initiated Trials (IIT) Program Manage all aspects of the IIT program, including proposal assessment, research agreements, material shipment, and ongoing collaborator check-ins. Work with the Clinical Research Committee to evaluate and select proposals. Partner with Legal and Finance to develop research contracts and budgets. KOL & External Partnerships Recruit clinicians, KOLs, and research partners for new and ongoing clinical studies. Serve as Butterfly Network's Clinical Science Liaison, providing scientific support and answering research-related questions from external collaborators. Team & Operations Leadership Manage and mentor clinical team members and consultants. Identify staffing and budget needs and delegate priorities effectively. Collaborate with R&D, Marketing, and other cross-functional leaders to align clinical programs with business goals. Qualifications Required: BS degree in Engineering or a Technical Field; advanced degree (PhD, MD, or equivalent) strongly preferred. 7-10 years of experience in the medical device or healthcare industry, with at least 6 years in clinical affairs or clinical trial management. Established network of KOLs and clinical research collaborators. Strong knowledge of GCP, IRB/Ethics Committee requirements, and clinical study design including statistical methodology. Experience writing SOPs and clinical research documentation. Excellent communication, leadership, and cross-functional collaboration skills. Preferred: Experience with AI/ML or Software as a Medical Device (SaMD). Familiarity with ultrasound imaging. Experience with regulatory authority audits. All regulatory affairs responsibilities have been removed. The reporting line now reflects the CMO directly. Values Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in… Patient-Centric Innovators: Our mission is THE mission. Empowered to Impact: Every voice matters. One Team, One Goal: Unity fuels progress. Growth Champions: We embrace challenges. Action-Oriented Achievers: We follow through, every time. Location Butterfly offers a hybrid work model for most positions, with team members spending two or more days a week in the office. While flexibility is key, we value in-person connections that spark creativity and teamwork. Our offices are designed for collaboration, with comfortable workspaces, stocked kitchens, and opportunities to connect with peers. This is a hybrid position that can be based in the San Francisco Bay Area or New York City, NY Benefits and Perks Comprehensive health insurance, encompassing dental and vision coverage, is provided to all our employees. As a health-tech company, we prioritize the well-being of our teams. We also contribute to Health Savings Account (HSA) accounts for all enrolled employees on an annual basis. Comprehensive Employee Assistance Program - we provide access to tools and resources to support your emotional health and day-to-day needs. 401k plan and match - we facilitate your retirement goals. Eligible employees will have the opportunity to participate in Employee Stock Purchase Plan (ESPP) Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact Parental Leave - we aim to provide our employees with time to bond with their growing family, along with additional support for primary caregivers to help transition back to work Competitive salaried compensation - we value our employees and show it Equity - we want every employee to be a stakeholder The opportunity to build a revolutionary healthcare product and save millions of lives! Compensation Our estimated salary for this role is between $230,000 - $245,000 + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand. For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status. Butterfly Network does not accept agency resumes. Butterfly Network is an E-Verify Company. Butterfly Network is an equal opportunity employer. Regardless of race, traits associated with 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. Butterfly requires security adherence responsibilities from all employees. These include: adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs. Safeguarding company data and systems from unauthorized access, modification, or destruction, contributing to the overall security posture of the organization. Immediately reporting any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access, following the established incident response procedure

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Vacancy posted 3 days ago
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