Manager or Senior Mananger, Medical Affairs Strategy Scientist
Genmab · Tokyo
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 Affairs Strategy Scientist (MASS) will lead the planning, coordination and execution of the designated product(s) launch for Genmab medical affairs department in collaboration with Medical Affairs Strategy Lead (MASL).
MASS will be responsible for the development and implementation of medical strategy and tactical programs as well as the medical deliverables in close alignment and collaboration with local Japan functions (i.e. commercial, R&D, etc) and Global Medical Affairs and represent Japan product medical strategy with co-commercial or co-development partners in Japan, as applicable.
Additionally, MASS will effectively partner with the Japan field medical team (Medical Science Liaison team) to ensure a successful execution of the Japan medical plan. This will be a high visibility/high impact role within the Genmab dynamic medical affairs organization.
This position is a home office based in Tokyo, Japan Responsibilities will include, but are not limited to, the following:
- Develop and execute the Japan medical affairs strategy and plan for designated product and the rapeutic area in collaboration with MASL
- Help identify and effectively interact with key thought leaders, patient advocacy groups and institutions to engage in scientific and medical exchange to meet the needs of patients
and advance the field of study
- Serve as the medical lead on lifecycle strategy, including evidence generation strategy development and execution of Phase 3b/4 studies
- Assure appropriate close coordination with the Japan commercial and marketing teams to support their efforts, including medical expert support of product launches
- Collaborate with the Japan field medical team and support reactive material develop to address their healthcare provider questions under global guidance
- Evaluate and manage Investigator Sponsored Trial efforts, including review of protocols and ongoing safety evaluations
- Collaborate with MSL manager on education and training for MSL
- Collaborate with medical information specialists on the development and adaptation of the Japan medical information letters and documents
- Collaborate with medical communications on the preparation of manuscripts, abstracts and presentations of scientific meetings as well as other scientific communications initiatives
- Contribute to the development of the global publications plan for designated products and support optimal execution of plan
- Contribute to the development of internal guidance and resource documents
- Provide guidance in the development of strategies to demonstrate the value of disease/products within the medical affairs with a focus on outcomes meaningful to payer and clinical decision-makers including Pricing and HTA
- Participates in medical review of branded and unbranded Japan promotional materials, market access and health economics and outcomes research (HEOR) materials and medical communications materials to ensure accuracy, currency, scientific balance and compliance with internal policies and procedures, as applicable
- Develops expert understanding of disease state and current medical and/or regulatory issues related to company products
- Participate in relevant cross-functional teams and task forces to represent the medical affairs
- team as needed
- Lead and support the Japan alliance partnership (i.e. Abbvie GK) and the development of the
- functional charters for the Japan form Medical Affairs perspective.
- Contribute as requested to the development/editing of other important medical communications to support the Medical Affairs activities, which might include briefing documents, written communications, Frequently Asked Question documents, etc.
- Provide medical monitoring and medical oversight for company sponsored medical affairs led
- interventional and observational clinical trials
- Assess and supervise Investigator Initiated Studies and Researches
Experience & Skills:
- A doctoral degree is required; a Life science or Clinical degree is preferred
- A minimum of3-5 years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry.
- Experience in clinical trial design and conduct (Phases II, Ill or IV), including interventional oncology clinical trials, is preferred
- Strong compliance knowledge and adherence to corporate compliance.
- Current working knowledge of country-specific legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with healthcare professionals.
- Proven ability to work independently, as well as in cross-functional networks.
- Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities, and a customer focus are necessary.
- Ability to work cross-functionally with numerous internal stakeholders in a high-matrixed environment
- Must be able to organize, prioritize, and work effectively in a constantly changing environment
- Business English level required
- This position requires travel (primarily domestic with some international travel)
Our commitment to bringing new medicines to the market to improve patients' lives is a strong motivation for employees at Genmab. Our aim is to foster a culture of excellence and innovation where employees are focused on clear priorities and are passionate about innovation. We work cross functionally and internationally as one team to gain the most from all competencies.
Genmab employees work with determination and with respect for each other to achieve our tasks and common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company.
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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。