Japan Medical Lead, Associate Director at Genmab US, Inc.

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

25 Feb, 26

Salary

0.0

Posted On

27 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oncology Expertise, Clinical Strategy, Trial Design, Medical Monitoring, Data Interpretation, Regulatory Knowledge, Cross-Functional Leadership, Communication Skills, Collaboration Skills, Decision-Making Skills, Scientific Rigor, Patient-Centric Focus, Clinical Development, Ethical Standards, Fast-Paced Environment, Innovative Solutions

Industry

Biotechnology Research

Description

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. 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 global–local 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。詳細は、以下リンク先よりご確認ください：Job Applicant Privacy Notice (genmab.com)

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Responsibilities

The Medical Lead (Japan) is responsible for providing strategic medical and clinical direction for assigned projects and trials, ensuring alignment with global development plans. This role involves overseeing trial-level medical activities and representing the medical function in interactions with health authorities and key opinion leaders.