Clinical Trial Manager (Rare Disease)

Location: Tokyo, Japan; hybrid work from the Tokyo office with weekly flexibility

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Lead and coordinate clinical trial activities in compliance with GCP and relevant regulatory requirements.
• Manage regional activities, global CROs, specialty vendors, deliverables, budgets, timelines, and contractual changes.
• Coordinate cross-functional study teams, support risk management, and monitor study metrics, quality, and performance.
• Develop trial plans and documentation and provide regular study status updates to senior management.
• Review patient profiles and data listings with clinical scientists, development leads, and study teams.
• Coach and mentor CRAs, CTAs, and other assigned program staff while contributing to SOP and process improvements.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related field.
• At least 7 years of clinical trial management experience in the pharmaceutical or biotechnology industry.
• At least 2 years of indirect or influence-based team management, including coaching and mentoring.
• Experience managing global, large, or complex studies and project teams, including global CROs and specialty vendors.
• Thorough understanding of drug development, clinical trial execution, ICH/GCP requirements, and local regulations.
• Strong leadership, communication, critical thinking, conflict resolution, time management, and organizational skills.

Nice to have

• Experience with rare disease or orphan indications.

Culture & Benefits

• Hybrid work environment with flexible working hours and vacation policies.
• Retirement benefits, equity compensation, and participation in an employee stock purchase plan.
• Internal and external training, LinkedIn Learning, and role-specific professional development.
• AI-enabled learning tools and access to digital assistants and internal resources.
• Global recognition programs, employee resource groups, and technology-enabled collaboration.