Director, Clinical Science (Medtech)

TL;DR

Director, Clinical Science (Medtech): Leading the clinical science function to develop evidence supporting regulated and unregulated health features with an accent on Software as a Medical Device (SaMD). Focus on designing clinical validation strategies, managing regulatory submissions, and building a high-performing team to drive product and business objectives.

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

Salary: $220,000–$245,000

Company

hirify.global is an advanced health and fitness wearable company dedicated to unlocking human performance through deep physiological insights.

What you will do

• Own the clinical evidence strategy across the entire portfolio of health features.
• Define clinical validation strategies including study design, endpoint development, and statistical analysis planning.
• Lead clinical strategy for FDA, CE Mark, and other regulatory pathways.
• Develop and approve key clinical deliverables such as protocols, SAPs, CSRs, and CERs.
• Build and mentor a high-performing Clinical Science organization.
• Partner with Product, Data Science, Engineering, and Regulatory teams to inform business decisions.

Requirements

• Advanced degree (PhD, MD, PharmD, etc.) in life sciences, medicine, or related field.
• 10+ years of experience in clinical science, research, or regulated healthcare environments.
• 5+ years of experience leading and developing clinical science teams.
• Proven experience leading clinical evidence generation for SaMD or digital health technologies.
• Deep expertise in clinical study design, regulatory submissions, and evidence generation strategy.
• Must be based in or willing to relocate to Boston, MA.

Nice to have

• Experience with wearable technologies, digital biomarkers, or remote patient monitoring.
• Familiarity with machine learning-enabled medical devices and algorithm validation.
• Experience interacting with FDA, Notified Bodies, or auditors.
• Working knowledge of R, SAS, Python, or SQL.

Culture & Benefits

• Competitive base salary with meaningful equity package.
• Comprehensive benefits package supporting health and well-being.
• Opportunity to own part of the company and share in long-term growth.
• Collaborative environment focused on innovation and human performance.