Genmab is looking for an experienced and dedicated Clinical Research Scientist to be part of our Medical (not medical affairs) team. This position is based in our Tokyo office.

As Clinical Research Scientist you will be part of a dedicated team local and global team and will constitute with your knowledge and experience in overseeing and developing clinical projects.

With a strong and solid pipeline, Genmab is heading towards a new era and as Clinical Research Scientist, you will have the possibility to work with different types of projects in various stages depending on your experience.

Responsibilities:

Key responsibilities include but are not limited to:

• Overseeing and developing clinical projects including component studies
• Providing not only strategic and scientific input but also development support for clinical plans and individual study protocols
• Performing medical monitoring, liaising with investigators and site personnel
• Performing preliminary and exploratory data analyses clinical trials
• Authoring clinical study reports; providing input on publication materials
• Participating in the development of clinical operating guides, maintenance of secure study files and reviewing results of these evaluations with appropriate management prior to implementation
• Leading and supporting regulatory submission documents such as briefing documents and relevant clinical modules in J-CTD, as well as, creating, reviewing and responding clinical questions/topics related to PMDA/MHLW interactions in close collaboration with global and local relevant R&D counterparts
• Participating and representing Japan at global Compound development Team and provide proactive clinical/scientific input related to Japan specific needs and/or requirements.
• Collaborating cross-functionally with other R&D functions both at local and global level for clinical projects related to Japan development.

Qualifications:

• A BSc or MSc level preferably within the medical, biological, pharmaceutical science or equivalent discipline
• Minimum of 5 years of experience monitoring/or associated role in clinical trials
• Proven skills from working in a project oriented and international organization
• Good oral and written communication skills
• Ability to travel to field sites
• Business level English (and native level Japanese, reading & writing)
• Valid permanent residency in Japan
• Native level Japanese in verbal, reading, & writing