Director, Clinical Science

Requirements

• Advanced degree (PhD, MD, PharmD, DrPH, MPH/MS with significant relevant experience, or equivalent) in life sciences, medicine, public health, epidemiology, biostatistics, or a related field.
• 10+ years of experience in clinical science, clinical research, medical devices, digital health, diagnostics, pharmaceuticals, or another regulated healthcare environment.
• 5+ years of experience leading and developing clinical science or clinical research teams.
• Demonstrated experience leading clinical evidence generation for regulated products, ideally including Software as a Medical Device (SaMD) or digital health technologies.
• Deep expertise in clinical study design, endpoint development, clinical validation, statistical analysis planning, and evidence generation strategy.
• Experience supporting FDA, CE Mark, or other regulatory submissions, including development of clinical evidence and participation in regulatory interactions.
• Experience authoring and reviewing key clinical and regulatory deliverables, including protocols, SAPs, CSRs, CERs, and submission documentation.
• Strong understanding of medical device and SaMD regulatory requirements, standards, and guidance.
• Proven ability to influence cross-functional stakeholders and drive decisions across Product, Data Science, Engineering, Regulatory, Quality, and Executive Leadership.
• Excellent written and verbal communication skills, with the ability to translate complex scientific and regulatory concepts for diverse audiences.
• Preferred experience with wearable technologies, digital biomarkers, cardiovascular health, women's health, sleep, metabolic health, or remote patient monitoring.

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Company Intel

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