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About the Role

Accountable for leading the development and implementation of the Japan Clinical Development Plan (JCDP) and Japan Product Strategy (JPS), incorporating local insights into molecules aligned with global strategy. Expected to provide medical/clinical expertise and support cross-functional teams.

Responsibilities

• Lead the development and implementation of the Japan Clinical Development Plan (JCDP) as part of the Japan Evidence Generation Plan (JEGP).
• Incorporate local medical/clinical insights into specific molecules according to global development strategy.
• Support other functional members in executing planned clinical activities and deliverables.
• Provide medical/clinical expertise to advance clinical development in Japan.
• Serve as Japan Product Strategy Team (JPST) Lead, guiding cross-functional team discussions for Japan Product Strategy (JPS) and JEGP.
• Obtain global CDP for JPST members to adapt into JCDP, ensuring maximization of patient and Amgen values.
• Provide local medical/clinical input on treatment paradigms, guidelines, and unmet needs to the global team for CDP and study design.
• Partner with Regulatory Affairs and Safety/Value & Access (V&A) to define and maintain product benefit/risk profile, facilitating local registration and reimbursement.
• Partner with Local Development Operations to provide strategic oversight and execution of clinical trials.
• Support Local Development Operations and Local Medical Affairs in clinical study activities.
• Lead the development of JPS and associated JEGP in alignment with Global Product Strategy (GPS)/Global Brand Plan (GBP) and obtain endorsement from Japan Portfolio Review Committee (JPRC).
• Support Local Medical Affairs, Marketing, and V&A in translating local/regional data gaps into actionable JEGPs.
• Encourage active and efficient work styles and foster an environment for members to utilize their full potential.
• Delegate, coach, and support JDMs, and develop their talent.
• Proactively share lessons learned and know-how from project activities to contribute to organizational Kaizen.

Requirements

• 5 or more years of clinical development experience in the biopharmaceutical industry.
• Experience with clinical project lead or proven industry collaboration in academia.
• Proven ability to lead multiple projects/indications and produce high-quality results.
• Understanding of Japanese regulatory agency organization, guidelines, and practices.
• Ability to negotiate with Japanese regulatory groups.
• Understanding of new drug product lifecycle and commercialization process.
• Understanding of other functions including Clinical Operations, Commercial, Regulatory, Medical Affairs, Value Access and Policy.
• In-depth understanding of and proven success in conceptualizing, designing, and conducting complex, global clinical trials.
• Sound scientific and clinical judgment.
• Experience in leading Clinical Development and NDA filing.
• Experience with clinical study management and conduct.
• Knowledge of GCP, PMDA regulations, guidelines, and compliance.

Skills

• Clinical development
• Clinical project lead
• Cross-functional team leadership
• Regulatory affairs
• Safety/Value & Access
• Clinical trial execution
• Medical affairs
• Product strategy development
• Evidence generation planning
• Data gap analysis
• Talent development
• GCP
• PMDA regulations

Location

• Japan

Work Type

• Full-time

Experience Level

• 5+ years clinical development experience
• Experience managing product lifecycle management
• Experience managing early phase clinical trials
• Experience with NDA filing

Education Level

• Medical degree
• PhD
• Master's degree or equivalent experience

About the Company

• Amgen