Associate Director, Clinical Trial Operations

TL;DR

Associate Director, Clinical Trial Operations: Independently lead clinical trial operations to deliver high-quality, cost-effective clinical trial data with an accent on GCP compliance, CRO/vendor oversight, and inspection readiness. Focus on study/program planning, site/vendor selection, and cross-functional execution of protocols, informed consents, and clinical study reports.

Location: Remote (Any State, US)

Salary: $180,000–$200,000 per year

Company

hirify.global is a biopharmaceutical company developing differentiated oncology therapies.

What you will do

• Serve as clinical operations study lead (and potentially program lead), owning project planning, budget/resource management, and oversight of CROs and project vendors.
• Manage execution of assigned clinical trials in accordance with Good Clinical Practices (GCP) and applicable national and international requirements.
• Identify, review, and select investigational sites and vendors; ensure vendors meet milestones within budget and timeline.
• Prepare and maintain study manuals, forms, plans, and documents; contribute to internal cross-functional study team meetings.
• Write and/or review clinical documents including protocols, informed consents, investigator brochures, and clinical study reports.
• Ensure inspection readiness throughout the trial lifecycle; recommend and implement process improvements and contingency plans.

Requirements

• Location: Must be based in the United States (any state)
• 7–10 years of applicable industry experience in drug development, including oncology experience; 3–5 years of personnel management experience.
• Experience leading global Phase 3 studies (in leadership or as a regional lead) is required.
• Direct experience selecting and managing global CROs and key vendors.
• Working knowledge of FDA and ICH Guidelines, including GCP E6(R2) requirements.
• Ability to travel for site visits, vendor visits, meetings, and presentations.

Culture & Benefits

• Competitive base salary, bonus, and equity plans.
• Unlimited vacation and 10 sick days annually.
• Medical, dental, and vision coverage.
• 401(k) with company matching.
• Annual performance-based bonus and long-term incentive units (equity) for full-time regular positions.

Hiring process

• Interviews to assess clinical operations leadership, vendor/CRO management, and GCP/FDA/ICH knowledge.
• Evaluation of experience with global Phase 3 study execution and cross-functional collaboration.