Director of Clinical Affairs

What you'll do

• Design and execute clinical studies from protocol development through final reports, including site management, enrollment, monitoring, and close-out.
• Manage clinical documentation, data operations, budgets, vendors, and regulatory compliance; support FDA submissions and audits.
• Build clinical operations processes and coordinate with internal teams, investigators, CROs, IRBs, and regulatory agencies.

What they ask for

• 10+ years of hands-on clinical operations experience, including at least 5 years in leadership, executing studies for FDA-regulated devices, SaMD/digital health, or combination products.
• Track record of leadership or critical participation in trials leading to FDA clearances/approvals or meaningful labeling expansions.
• 7+ years of cross-functional program management involving clinical, engineering, and regulatory teams.
• Bachelor's degree required; experience authoring clinical protocols, IRB/Ethics submissions, and informed consent forms.

Nice to have

• Advanced degree (MS, MPH, PhD, or clinical doctorate); ACRP or SOCRA certification is a plus.
• Experience with biosensing devices, consumer health technology, wellness platforms, real-world evidence, or decentralized/hybrid trials.

Pay

$200,000 – $250,000 USD base salary

Tools

FDA regulations (21 CFR Parts 11, 50, 56, 812, 820), ICH-GCP, ISO 14155, SaMD, FDA Digital Health frameworks, IDE, De Novo, 510(k)