Director, Clinical Research & Regulatory Affairs

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.
• I nvestigator 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.

Requirements

• 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

Benefits

Additional Information

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.

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