Japan Development Lead, Development TA (General Medicine)

Location: Tokyo, Japan

Company

hirify.global is a biopharmaceutical company developing medicines and advancing clinical research.

What you will do

• Lead the development and implementation of Japan Clinical Development Plans as part of Japan Evidence Generation Plans, aligned with global development strategy.
• Provide local medical and clinical insights on treatment paradigms, guidelines, unmet needs, study design, and clinical development strategy.
• Partner with Regulatory Affairs, Safety, Value & Access, Medical Affairs, Marketing, and Development Operations on clinical, regulatory, safety, reimbursement, and commercialization activities.
• Provide strategic oversight for clinical trials and support investigator meetings, regulatory inspections, local training, and clinical site visits.
• Lead the Japan Product Strategy Team in developing Japan Product Strategy and associated evidence generation plans, securing portfolio committee endorsement.
• Coach and support Japan Development Managers, share project learnings, and contribute to organizational improvement.

Requirements

• At least 5 years of clinical development experience in the biopharmaceutical industry, including clinical project leadership or proven industry collaboration in academia.
• Ability to lead multiple projects or indications and deliver high-quality results.
• Medical degree, PhD, or equivalent experience with a master’s degree.
• Fluent English and business-level Japanese, both written and spoken, are required.
• Knowledge of Japanese regulatory agencies, PMDA regulations, GCP, clinical study management, and drug development and commercialization processes.
• Proven experience conceptualizing, designing, and conducting complex global clinical trials, with sound scientific and clinical judgment.

Nice to have

• Product life-cycle management experience across functions.
• Experience managing early-phase clinical trials.
• Experience with NDA filing.

Culture & Benefits

• Cross-functional collaboration across Clinical Development, Clinical Operations, Commercial, Regulatory, Medical Affairs, and Value & Access.
• Team environment focused on trust, resilience, effective collaboration, and enabling each member’s potential.
• Opportunities to coach colleagues, develop talent, share expertise, and contribute to organizational Kaizen.