Director, Clinical Affairs (Hybrid - Sunnyvale)

Location: Hybrid role based in Sunnyvale, California, United States

Salary: $208,000–$256,000 USD per year, with potential performance-based bonuses.

Company

hirify.global is a medical technology company developing a point-of-care EEG platform for rapid seizure detection and the management of serious neurological conditions in acute care settings.

What you will do

• Develop and execute clinical evidence strategies for current and future medical device products.
• Plan, design, and manage feasibility, pivotal, post-market, and registry clinical trials.
• Collaborate with Regulatory Affairs, R&D, Go-to-Market, and Commercial teams to translate business needs into scientifically valid clinical plans.
• Select and manage key opinion leaders, serving as the primary clinical contact for KOLs and conference activities.
• Oversee clinical protocol development, data analysis, interpretation, reporting, presentations, abstracts, and publications.
• Manage clinical budgets and resources while establishing clinical quality systems and standard operating procedures.

Requirements

• Bachelor’s degree in life science, engineering, or a related discipline; an advanced degree such as Ph.D., M.D., Pharm.D., or Master’s is highly preferred.
• At least 8 years of progressive experience in Clinical Research or Clinical Affairs within the medical device industry.
• Proven experience designing, executing, and reporting pivotal randomized clinical trials for medical devices.
• Deep working knowledge of FDA regulations under CFR Title 21, ICH-GCP, and ISO 14155.
• Ability to manage multiple projects, solve problems proactively, and operate in a fast-paced environment with shifting priorities.
• Hybrid work requires regular presence in Sunnyvale, California.

Culture & Benefits

• Performance-based incentive compensation and equity opportunities.
• Employer-paid employee health benefits and partial coverage for dependent health, dental, and vision plans.
• Employer-paid life and long-term disability insurance.
• 401(k) with company match and employee stock purchase plan.
• Flexible paid time off, 13 paid holidays, wellness days, and parental leave.
• Mission-minded work environment focused on improving critical care through rapid seizure detection technology.