In this role, the clinician serves as the internal medical expert supporting infant safety, product strategy, and safety review while also acting as the external medical voice for healthcare providers and clinical advisors. The work includes reviewing adverse events, advising on study design and regulatory materials, supporting clinical education, and contributing medical input to AI-enabled product and data workflows focused on infant health, safety, and sleep. The position combines medical affairs, clinical study leadership, and commercial support in a lean, cross-functional environment.
Key Responsibilities
- Serve as the primary internal medical resource for product, safety, regulatory, marketing, and clinical strategy decisions.
- Review adverse event reports, product complaints, and post-market safety signals; provide medical assessment and causality determination.
- Support safety narratives, risk-benefit analyses, failure mode assessments, and post-market surveillance activities.
- Provide medical review and sign-off on clinical protocols, informed consent forms, and clinical investigation plans.
- Lead or serve as Principal Investigator on company-sponsored clinical studies and post-market follow-up studies.
- Review interim and final study data, clinical study reports, and safety findings; escalate concerns as needed.
- Develop internal medical education, FAQs, and training materials for sales, marketing, customer experience, and product teams.
- Support commercial and external communications by reviewing promotional materials, HCP-facing content, and medical claims.
Required
- MD or DO degree.
- Board certification in Pediatrics strongly preferred; other relevant clinical specialties may be considered.
- Current or inactive U.S. medical licensure.
- 3-7 years of combined clinical practice and/or industry experience in medical affairs, clinical development, or a medical science liaison role.
- Direct patient care experience.
Preferred
- Board certification in Pediatrics.
- Experience in medical device, digital health, consumer health, or life sciences.
- Familiarity with infant monitoring, cardiorespiratory physiology, pulse oximetry, or pediatric sleep medicine.
- GCP certification or willingness to obtain it before clinical study initiation.
- Working knowledge of FDA IDE regulations and IRB processes.
- Prior startup or early-stage company experience.
Benefits & Perks
- Multiple medical plan options, plus dental, vision, life, and disability coverage.
- Mental health support, EAP access, and fitness incentives.
- 401(k) plan with company match and employee stock purchase program.
- Potential equity grants.
- Generous flexible PTO, including Flex Fridays.
- Paid parental leave up to 14 weeks.
- Remote/hybrid work options.