TMC CLINICAL DEVELOPMENT CONSULTING, INC.
TMC Clinical Development Consulting, Inc. bridges pharmaceutical and biotech innovation between the United States and Japan. Led by Tomoko Maeda-Chubachi, MD, PhD, MBA, the firm provides clear, strategic guidance across clinical development, regulatory planning, and cross-cultural collaboration.
Connect with TMCWHAT WE OFFER
TMC Clinical Development Consulting, Inc. is an independent consulting firm supporting pharmaceutical and biotechnology organizations as they navigate complex global development. With a particular focus on collaboration between the U.S. and Japan, TMC helps teams move forward with confidence, clarity, and strategic alignment.
Founded by Tomoko Maeda-Chubachi, MD, PhD, MBA, TMC combines rigorous scientific and regulatory expertise with cross-cultural fluency and decades of hands-on leadership experience.
Over two decades leading clinical development, medical affairs, and regulatory alignment—from early-phase studies to global launch preparation.
Expert knowledge of highly regulated development processes, with deep experience in risk assessment, risk mitigation, and governance-level decision-making.
Specialized strength in collaboration between U.S. and Japanese stakeholders, enabling smoother communication, efficient progress, and shared strategic direction.
Leadership across both large pharmaceutical systems and resource-limited biotech environments, bringing operational efficiency and adaptability to teams of any size.
A commitment to empowering the next generation of drug development professionals through structured mentorship, coaching, and industry leadership programs.
ABOUT DR. TOMOKO MAEDA-CHUBACHI, MD PhD, MBA
Dr. Tomoko Maeda-Chubachi is an advisor and consultant with over 20 years of experience in global drug development across pharmaceutical and biotech environments. She has led clinical development and medical affairs functions in both multinational pharmaceutical companies and emerging biotech organizations, including serving as Chief Medical Officer at Pelthos Therapeutics.
Tomoko has directed global development teams responsible for eight regulatory approvals across multiple regions, including Xalatan, Xeljanz, Taltz, Vtama, and Zelsuvmi. Her leadership spans First-in-Human studies through launch preparation, with deep expertise in risk assessment, regulatory navigation, and cross-functional decision-making.
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Known for her strategic communication and cultural fluency, Tomoko has successfully facilitated partnerships between U.S. and global stakeholders, enabling teams to remain productive, agile, and aligned—even in resource-limited environments. She works closely with executive and board-level leaders to guide strategy, governance, and forward-looking planning.
Beyond her industry accomplishments, Tomoko is deeply committed to mentorship. She has supported the professional growth of more than 100 pharmaceutical leaders through programs including Women in Bio, Dermatologists in Industry, Drug Development Career Promotion, and the Japan Alliance of Medical School Startups (JAMZ).
PARTNERING WITH GLOBAL LEADERS IN INNOVATION
Past Work & Publications
Tomoko regularly shares her expertise through publications, presentations, and speaking engagements that support innovation and strengthen the global drug development community.
CONTACT
For organizations seeking strategic guidance in global drug development, regulatory planning, or cross-cultural collaboration, TMC is ready to help you navigate your next steps.
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