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extranotordinary 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 Japans 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 Genmabs 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.

Required Technical Skills and Competencies Medical / Scientific Expertise

• 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

Clinical Development & Trial Execution

• 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

Strategic / Cross-functional Leadership

• 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 globallocal perspectives

Communication & External Engagement

• 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

Mindset & Competency Foundations

• 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

#LI-DNP

場所

ジェンマブは可能な限り柔軟な働き方を取り入れることで社員のワークライフバランスの向上に取り組んでいます

私たちのオフィスはオープンな環境の中で従業員同士がつながることを目的としていますオフィスでもリモートワークでもお互いにつながることを大切にしイノベーションを生み出します

ジェンマブについて

ジェンマブは革新的抗体医薬を通じて患者さんの生活を向上させることを目指すグローバルバイオテクノロジー企業です

25年間情熱的で革新的そして協力的なチームが次世代抗体技術プラットフォームを開発しトランスレーショナルサイエンス定量科学データサイエンスを活用することで独自のパイプラインを確立してきましたこのパイプラインには二重特異性T細胞エンゲージャーbispecific T-cell engagers抗体薬物複合体ADC次世代免疫チェックポイントモジュレーターエフェクター機能強化抗体などが含まれています

ジェンマブのビジョンは2030年までに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ることです

ジェンマブは1999年に設立されたデンマークコペンハーゲンに本社を構え北米ヨーロッパアジア太平洋地域に国際的な拠点を展開しています

ジェンマブでは候補者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います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

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