Japan Medical Lead, Associate Director

ジェンマブは革新的な抗体医薬の開発に注力し、患者さんの生活を改善することに力を尽くしています。

私たちは、extra[not]ordinary® な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。

ジェンマブは思いやりがあり、率直で、患者さんに貢献したいという強い思いを持った人たちがともに働き、科学に基づく変化をもたらします。大胆さと高潔性を持って行動し、新しい未来をつくることを目指すこと が、この使命を果たすために不可欠だと信じています。

私たちは大きな志を掲げ、楽しく、そして思いやりの心を忘れずに、日々意義のある仕事に取り組んでいます。私たちは、個々のユニークな貢献を受け入れ、それらを原動力として、患者、ケアパートナー、ご家族、そして社員のニーズを満たす革新的なソリューションを生み出し、育み、維持するグローバルな企業文化の構築に努めています。

私たちの想いに共鳴し、自分らしく活躍できそうだと感じたら、ぜひ一緒に働きましょう。

Position Summary:

The Medical Lead (Japan) is a key leadership role within the Japan R&D organization, responsible for providing strategic medical and clinical direction for assigned projects and trials. The position serves as the primary owner of all medical and clinical input for Japan, driving the design, execution, and analysis of clinical studies in close collaboration with Japan Clinical Research Scientists and global clinical counterparts.

The Medical Lead ensures that Japan's clinical strategy is aligned with global development plans, provides deep oncology expertise, leads trial-level medical activities, and represents the medical function in interactions with health authorities, investigators, and key opinion leaders.

This role requires strong scientific acumen, strategic thinking, cross-functional leadership, and the ability to establish effective partnerships both internally and externally. The Medical Lead plays a critical role in shaping the development of Genmab's current and future product candidates and advancing innovative therapeutic options for patients in Japan.

Primary roles & responsibilities include, but are not limited to;

• Accountable for final medical/clinical input, process, conceive and execute clinical strategy for specified projects/trials in Japan, in close collaboration and alignment with Japan Clinical Research Scientists. This also includes the creation of Japan clinical strategy and alignment with global counterparts accordingly.
• Provide medical expertise in oncology, including relevant, up-to-date knowledge of competitor products
• Act as trial-designated Medical Lead, oversee and directly contribute to the planning, start, conduct and analysis of the designated trials in Japan including all its key milestones and elements (design, protocol development, medical monitoring, dose escalation committee, data interpretation, publication, etc).
• Contribute in an active and ongoing manner to the scientific, medical and commercial development of current and future product candidates (internally and externally developed)
• Interact with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel medical methods development and new potential targets
• Act as medical expert and provide proactive input in interactions with Health Authorities (i.e. PMDA, MHLW)
• Establish productive, interactive relationships with relevant internal departments (R&D, Medical Affairs, Commercial), as well as the medical and scientific community in Japan. Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Create and proactively contribute to medical deliverables: clinical development plans, concept sheets, briefing books, and label and marketing application dossier
• Contribute and coordinate medical input to preclinical development of candidate therapeutic antibodies, if needed
• Participate in selection of the right product candidates for clinical development, etc.

• M.D. degree with specialty training in oncology, hematology, internal medicine, or related fields
• Strong, up-to-date understanding of oncology disease biology, treatment paradigms, and competitive landscape
• Ability to provide high-quality medical input into clinical strategy, trial design, and protocol development

• Proven experience contributing to or leading clinical trials, including study design, medical monitoring, safety assessment, dose escalation committees, and data interpretation
• Understanding of ICH-GCP, global clinical development processes, and Japan regulatory requirements (e.g., PMDA/MHLW expectations)
• Ability to develop clinical development plans, concept sheets, briefing documents, and other key medical deliverables

• Demonstrated ability to translate scientific and clinical knowledge into actionable clinical strategies for Japan
• Strong collaboration skills with Clinical Research Scientists, Clinical Operations, Regulatory Affairs, Medical Affairs, and global teams
• Effective decision-making skills, with the ability to manage complex issues and balance global-local perspectives

• Strong communication skills to interact with investigators, KOLs, medical experts, and external partners
• Ability to represent the medical function in regulatory interactions and scientific discussions
• Experience presenting data and clinical strategies to internal governance bodies and external stakeholders

• Strategic, proactive, and scientifically rigorous mindset
• High ethical standards, patient-centric focus, and strong ownership of clinical quality
• Ability to work in a fast-paced, evolving environment with cross-cultural teams