Director, Clinical Research & Regulatory Affairs

Butterfly Network•New York, NY

6d•$230,000 - $245,000•Hybrid

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience with AI/ML or Software as a Medical Device (SaMD).
Familiarity with ultrasound imaging.
Experience with regulatory authority audits.

Responsibilities

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.
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.
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.
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.