About the Role
Lead early- and late-stage clinical development programs across multiple oncology assets, providing medical leadership and scientific expertise. Collaborate with cross-functional teams, manage clinical trials, and partner with global development teams to bring transformative treatments to patients worldwide.
Responsibilities
- Provide medical leadership and scientific expertise for oncology clinical development projects.
- Lead early- and late-stage development programs from a medical perspective.
- Collaborate with cross-functional internal teams, CROs, investigators, and Key Opinion Leaders (KOLs).
- Manage the progress of clinical trials and ensure high-quality medical oversight.
- Partner closely with global development teams and international counterparts.
- Work with Regulatory Affairs to support interactions with health authorities.
- Develop and execute publication strategies and scientific communication activities.
- Provide medical expertise as a core member of oncology development teams.
- Review clinical trial protocols, regulatory submissions, and other development documents.
- Provide medical guidance on immune-related adverse events (irAEs), adverse events (AEs), and serious adverse events (SAEs), including communication with internal and external stakeholders.
- Deliver scientific and medical education to internal teams through presentations and training.
- Lead strategic planning for early- and late-stage oncology development programs.
- Develop clinical development strategies and key study documents.
- Coordinate with internal stakeholders, CROs, and external experts to ensure successful study execution.
- Collaborate closely with global project teams throughout the development lifecycle.
- Support interactions with regulatory authorities.
- Plan and manage domestic advisory board meetings.
- Support global advisory activities, including collaboration with leading researchers and healthcare professionals.
- Prepare and review documents for regulatory submissions.
- Participate in regulatory meetings and respond to health authority inquiries as the clinical representative.
- Develop publication strategies and oversee publication activities.
- Author or contribute to scientific manuscripts, review articles, and other publications.
- Attend domestic and international scientific congresses to gather and share medical insights.
- Support scientific exchange between healthcare professionals and global medical teams.
Requirements
- Medical Doctor (MD) license required.
- Minimum 5 years of clinical practice experience in Japan, including oncology.
- Experience in pharmaceutical-sponsored clinical trials, academic clinical research, or investigator-initiated studies (3+ years preferred).
- Native-level Japanese.
- Business-level English with the ability to participate in scientific discussions, medical meetings, and daily collaboration with global teams. Strong conversational English is essential.
Skills
- Oncology clinical development
- Medical leadership
- Scientific expertise
- Clinical trial management
- Regulatory affairs
- Publication strategy
- Scientific communication
- Cross-functional collaboration
- Global development teams
- Key Opinion Leaders (KOLs)
Location
- Japan
Work Type
- Full-time
Experience Level
- 5+ years clinical practice experience in Japan
- 3+ years experience in clinical trials
Education Level
- Medical Doctor (MD) license
- PhD in Medicine, Pharmacy, Nursing, or Life Sciences is preferred
Benefits
- Lead innovative oncology clinical development across early- and late-stage programs with a strong global pipeline.
- Work closely with global teams, KOLs, and regulatory authorities, gaining significant international exposure and influence.
- Join a collaborative network of experienced physician leaders in Japan and globally, with strong mentorship and knowledge sharing.
- Enjoy diverse long-term career opportunities across clinical development, medical affairs, and global leadership roles.
- Make a meaningful impact by helping bring cutting-edge cancer therapies to patients worldwide.
About the Company
- Leading global research-driven biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines.
- Strong presence in oncology and one of the industry's most robust clinical development pipelines.
- Invests heavily in cutting-edge science and global collaboration to bring transformative treatments to patients worldwide.
- Offers extensive opportunities to work with international teams, renowned medical experts, and key opinion leaders while contributing to both early- and late-stage clinical development programs.
