About this role
Job title: Clinical Development Lead, Japan
About the Role This role is an extended member of the Global Clinical Team representing Clinical Development Japan. It leads medical and clinical development activities in Japan, collaborating with GPCH/CDMD on Japan-initiated studies and post-DDP strategy to enable regulatory approval and market access for one or more indications and programs in Japan.
What You'll Do
- Serve as extended member of GCT representing CD-J and drive clinical development in Japan.
- Be a member of JPT and lead clinical development in Japan.
- Provide medical lead for Japan-initiated studies in collaboration with GPCH/CDMD.
- Post-DDP: lead development and execution of Japan clinical strategy; contribute to CDP and alignment with TPP for regulatory approval and market access.
- Input to the creation of clinical components of key documents and ensure alignment with CDP/TPP; support registration, market access, and maintenance of licenses.
- Act as the medical/scientific expert, interacting with external stakeholders and internal teams; lead HA activities including briefing books.
- Contribute to TA strategies in Rheumatology.
- Provide onboarding, coaching, and mentoring; foster a strong Clinical Development culture.
- Ensure timely reporting of adverse events and compliance issues; maintain 100% on-time completion of training and compliance requirements.
What We're Looking For
- Education: Advanced degree in life sciences/healthcare (MD, PhD, PharmD preferred); advanced clinical training aligned with the TA; subspecialty may be needed.
- Experience/Professional requirements: ≥5 years in clinical research/drug development in industry; experience across Phases I–IV and submissions; thorough knowledge of GCP and GPSP; regulatory/clinical development experience with health authorities.
- Demonstrated ability to build scientific partnerships with key stakeholders; leadership and cross-functional collaboration; strong written and verbal communication; negotiation and diplomacy skills.
- English: Fluent (or able to communicate effectively in English).
Nice to Have
- Specialization in a subspecialty; advanced clinical training/knowledge aligned with the therapeutic area.
- Direct experience in Rheumatology TA is advantageous.