As a key member of the medical and clinical development team, you will provide medical and scientific leadership to support the successful development of innovative therapies in oncology. You will collaborate with global and regional teams to drive clinical strategies, ensure high-quality clinical documentation, and contribute to regulatory and scientific activities.
Medical and Scientific Leadership
- Provide medical/scientific expertise and contribute to the development and review of clinical documents, including study concept sheets, protocols, clinical study reports, Investigator’s Brochures, publications, and other relevant materials.
- Review and approve clinical documents related to assigned clinical studies to ensure scientific quality and compliance.
- Conduct medical monitoring activities for assigned clinical programs, as required.
- Oversee medical and scientific aspects of clinical trials, including identification and management of scientific and medical risks in collaboration with cross-functional teams.
- Support the review, analysis, and interpretation of clinical study data.
- Contribute to the communication and publication of study results.
Clinical Development Strategy & Cross-Functional Collaboration
- Develop and support clinical development strategies for assigned oncology programs to establish safety and efficacy and support regulatory approval in Japan and globally.
- Provide insights into the local medical environment and contribute to regional development strategies.
- Collaborate with global teams to develop biomarker strategies and support translational research initiatives.
- Contribute to integrated development plans, regulatory submission documents, publications, and other clinical development activities.
- Build and maintain strong relationships with investigators, Key Opinion Leaders (KOLs), regulatory authorities, ethics committees/IRBs, consultants, and academic institutions.
- Participate in cross-functional project teams, providing medical/scientific input into business planning, project strategy, and evaluation of potential development opportunities.
- Support business development activities by providing medical expertise for evaluation of strategic opportunities.
Global & Regional Team Collaboration
- Act as the clinical representative in global and regional project teams.
- Provide medical input into global development strategies and regulatory approaches.
- Contribute to clinical sections of regulatory submission documents
- Collaborate with international colleagues across different time zones, including Europe and the US.
Requirements
- Minimum of 5 years of clinical development experience in oncology within the pharmaceutical industry.
- Fluent English communication skills with native-level Japanese proficiency.
- Strong scientific background with a minimum bachelor’s degree in pharmacology, biology, life sciences, or a related field.
- Ph.D. preferred for Clinical Scientist candidates.
- MD qualification required for Medical Director candidates.
- Experience working collaboratively in cross-functional and international teams.
- Ability to participate in evening/night calls with global colleagues when required.
- Willingness to engage with KOLs and clinical investigators.
- Ability to effectively lead projects and make decisions in complex, uncertain, and evolving environments.
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