Head of Clinical Development (Biotech)

Location: South San Francisco, California, United States

Company

hirify.global is a biotechnology company developing medicines for age-related diseases by reprogramming the epigenome and using functional genomics, pooled perturbation screening, and artificial intelligence.

What you will do

• Lead and orchestrate clinical development activities with external partners.
• Design clinical trial protocols and author regulatory submissions.
• Contribute to regulatory interactions with the US FDA and international agencies.
• Resolve logistical bottlenecks affecting clinical study progress.
• Contribute to executive-level budgeting, goal setting, and technical review decisions.
• Build and operate the clinical development team ahead of first-in-human dosing.

Requirements

• M.D. or equivalent clinical training.
• Experience planning and orchestrating first-in-human trials.
• Experience working with both US FDA and non-US regulatory agencies, such as the Australian TGA.
• Deep knowledge of Good Clinical Practice.

Nice to have

• Experience in metabolic and liver disease therapeutic areas.
• Experience leading clinical development teams across multiple therapeutic areas.
• Experience developing gene therapy, nucleic acid therapy, or cell therapy products.
• Experience managing Phase 1/2 and Phase 3 clinical trials.

Culture & Benefits

• Health, dental, and vision insurance.
• 401(k) with company match.
• 20 days of paid time off per year plus holidays.
• Paid parental leave.
• Meals and snacks provided on-site.