Director, Clinical Operations (Medtech)

TL;DR

Director, Clinical Operations (Medtech): Leading the clinical operations function to execute studies supporting regulated and unregulated health features with an accent on Software as a Medical Device (SaMD) compliance. Focus on building a high-performing team, managing CRO partnerships, and ensuring rigorous adherence to FDA and ISO 14155 standards across the product lifecycle.

Location: Must be based in or relocate to Boston, MA

Salary: $210,000–$230,000

Company

A health and performance technology company focused on wearable devices and data-driven health insights.

What you will do

• Own the clinical operations strategy for the entire portfolio of health features.
• Develop operational models for both internal and CRO-managed validation studies.
• Lead study startup, execution, monitoring, and closeout activities.
• Oversee participant recruitment, retention, and study logistics.
• Manage external vendor governance, including CROs and technology providers.
• Build and mentor a high-performing Clinical Operations organization.

Requirements

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of experience in clinical operations, medical devices, or digital health.
• 5+ years of experience leading multidisciplinary clinical operations teams.
• Deep expertise in GCP, FDA regulations, and ISO 14155.
• Proven experience managing CRO-managed studies and internal research programs.
• Strong communication skills for translating complex regulatory concepts to stakeholders.

Culture & Benefits

• Competitive base salary with meaningful equity packages.
• Comprehensive health and wellness benefits.
• Opportunity to work on cutting-edge wearable health technology.
• Inclusive environment that values character and diverse experience.
• Commitment to long-term employee growth and company success.