Tatsunari Ishioka
Saitama City
Summary
With over 20 years of experience in the pharmaceutical industry, I have led clinical trials ranging from First-in-Human studies to global Phase III registrational programs. My career includes management of clinical operations in Japan and the US, business planning, licensing activities, and hands-on drug development in both common and ultra-orphan disease areas. I have consistently implemented operational improvements, led global cross-functional teams, and contributed to successful regulatory submissions and product approvals. My focus remains on contributing to human health through innovative medicine development and ensuring opportunity for patients with unmet medical need.
Overview
22
22
years of professional experience
2
2
Certifications
Work History
Director, Clinical Project Lead
Alexion Pharma GK
10.2023 - Current
- Lead the Global Clinical Trial Team for Phase III studies in ATTR-CM.
- Managed CROs and vendors, clinical trial budgeting, and oversight of CSR/CTD documentation.
- Facilitated and chaired global team meetings, managing risks and resolving issues.
- Achieved database lock within planned timelines and acquired manufacturing and marketing approval in March 2025.
- Oversight ICCC study in Hypoparathyroidism.
Head of Clinical Operations Department
Alexion Pharma GK
08.2019 - 09.2023
- Oversight of all clinical operations conducted in Japan for over 10 protocols.
- 5 successful product approvals.
- People management (up to 10 staff), team development, and process optimization.
- Championed global collaboration and visibility of Japanese operations.
- Planned and established new organizational structures for local trials.
Japan Project Lead
Alexion Pharma GK
10.2018 - 07.2019
- Managed Phase III global trials for PNH and aHUS in Japan, including CRO management, regulatory inspection readiness, and CTD review.
- Led successful remote global inspections, achieving marketing approvals for 2 compounds.
Clinical Scientist
MSD K.K.
12.2015 - 09.2018
- Developed study protocols and case report forms for Phase II and III trials in asthma and chronic cough.
- Provided strategic clinical insights for trial design, optimized patient selection, and contributed to regulatory submissions and medical monitoring.
License Department
Nippon Kayaku Co., Ltd.
10.2013 - 12.2015
- Assessed in-licensing candidates, conducted market research and stakeholder interviews, evaluated nonclinical/clinical data.
- Met over 200 biotech companies and conducted 2 due diligences.
Business Planning
Nippon Kayaku Co., Ltd.
09.2012 - 09.2013
- Supported cross-functional business planning, mid- and long-term strategy, coordination of licensing, M&A candidate evaluation, and new business proposals.
Study Lead
Nippon Kayaku Co., Ltd.
02.2010 - 08.2012
- Oversight 3 clinical trials in US
- Designed and managed development plans, coordinated with CROs, wrote key study documents, and represented as abstract co-author at ASCO 2012.
CRA
Nippon Kayaku Co., Ltd.
04.2003 - 01.2010
- Managed First-in-Human and global phase I-III studies in oncology (monitored up to 200 patients at 32 sites).
- Coordinated with non-clinical teams and investigators for safety oversight, rapid enrollment, and protocol compliance.
Education
Master of Science - Dental Science
Tokyo Medical And Dental University
Tokyo 04.2001 -
Skills
End-to-end experience in drug development from First-in-Human to global Phase III trials
Certification
TOEIC 900 (2015-03)
Timeline
Director, Clinical Project Lead
Alexion Pharma GK
10.2023 - Current
Head of Clinical Operations Department
Alexion Pharma GK
08.2019 - 09.2023
Japan Project Lead
Alexion Pharma GK
10.2018 - 07.2019
Clinical Scientist
MSD K.K.
12.2015 - 09.2018
License Department
Nippon Kayaku Co., Ltd.
10.2013 - 12.2015
Business Planning
Nippon Kayaku Co., Ltd.
09.2012 - 09.2013
Study Lead
Nippon Kayaku Co., Ltd.
02.2010 - 08.2012
CRA
Nippon Kayaku Co., Ltd.
04.2003 - 01.2010
Master of Science - Dental Science
Tokyo Medical And Dental University
04.2001 -
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