Japan Development Lead, Development TA (General Medicine)
On-siteTokyo, Tokyo, Japan
Job Summary
Lead the development and implementation of the Japan Clinical Development Plan (JCDP) and Japan Product Strategy (JPS), adapting global clinical development plans to local medical insights while supporting cross-functional team discussions. Obtain global CDPs for JPST members, ensuring they maximize patient value through multifaceted considerations. Provide medical/clinical expertise to advance clinical development by delivering local input on treatment paradigms, guidelines, and unmet needs to the global team. Partner with Regulatory Affairs and Safety/Value & Access to define product benefit/risk profiles, facilitate local registration, and provide leadership on CTD submissions and regulatory responses. Support Local Development Operations in strategic oversight of clinical trials, including investigator meetings, regulatory inspections, and site co-visits. Lead the development of JPS and associated Japan Evidence Generation Plans (JEGPs) aligned with global strategies, capturing local data gaps into actionable plans. Encourage efficient work styles, delegate to JDMs, and share lessons learned to drive organizational Kaizen.
Required Qualifications
- 5 or more years of clinical development experience in the biopharmaceutical industry
- experience with clinical project lead
- proven industry collaboration in academia
- Proven ability to lead multiple projects/indications and produce high-quality results
- Medical degree, PhD, and/or equivalent experiences of Master's degree
- Fluency in English, both oral and written communications
- Business Japanese skill, both oral and written communications
Desired Qualifications
- Experience to manage product life cycle management in collaboration across functions as a lead and/or representative from Clinical Development
- Experience to manage early phase of clinical trial
- Experience with NDA filing
- Knowledge/ Experience Understanding of Japanese regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
- Understanding of new drug product lifecycle and commercialization process with understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy
- In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
- Medical knowledge in the relevant therapeutic area
- 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
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