Director of Clinical Studies (Microbiome Therapeutics)

Location: Hybrid - San Francisco, CA, United States

Salary: $223,200-$248,000 per year

Company

hirify.global develops microbiome-based products, including rationally designed live synbiotics, using genome sequencing and computational approaches to identify proprietary bacterial strains.

What you will do

• Design, update, and manage clinical health surveys, ensuring data integrity and coordinating dashboard development, reporting, and analysis.
• Support customer studies and generate clinical insights for product, marketing, and revenue teams.
• Coordinate concurrent single-site, multi-site, and investigator-initiated clinical trials, including protocol design, daily operations, data collection, and data management.
• Coordinate internal teams, clinical collaborators, vendors, study sites, site selection, training, monitoring visits, product logistics, participant issues, and adverse-event follow-up.
• Maintain clinical quality-control procedures and regulatory documentation, support IRB submissions, and ensure compliance with Good Clinical Practice and applicable regulatory requirements.
• Collaborate with marketing and creative teams on conference materials, presentations, white papers, case studies, blog posts, email communications, and website copy.

Requirements

• Bachelor’s degree in biological science, nursing, dietetics, life sciences, medical science, or a related field.
• At least 3 years of experience in clinical trial coordination, program or project management, and clinical organizations.
• Knowledge of ICH GCP standards, regulatory guidelines, and clinical research safety procedures.
• Experience with Investigator Brochures, Investigational New Drug Applications, clinical study infrastructure, and electronic data capture or survey tools such as Qualtrics.
• Strong organizational, communication, critical-thinking, coordination, and cross-functional collaboration skills.
• Ability to manage multiple projects under tight time constraints, work independently, learn new systems quickly, and understand microbiome science or develop that knowledge quickly.

Culture & Benefits

• Highly collaborative, cross-functional environment spanning science, engineering, medicine, manufacturing, marketing, data, and research and development.
• Medical, dental, and vision coverage.
• Commuter benefits, life and short-term disability insurance.
• Company match on 401(k).
• Flexible Time Off and equity.