Senior Manager, Clinical Research Scientist
Genmab
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。
The Role:
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
#LI-DNP
私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。
互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。
ジェンマブ株式会社では、お客様の個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しております。ご応募いただく際は、個人情報の取扱いにご同意いただいた上、ご応募ください。