Senior Manager or Manager, Medical Affairs Strategy Scientist
Genmab
Japan
Posted on Dec 3, 2024
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。
Responsibilities will include, but are not limited to, the following:
- Develop and execute the Japan medical affairs strategy and plan for designated products and therapeutic areas 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 for product launches.
- Collaborate with the Japan field medical team and support reactive material development 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 the 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 for scientific meetings, as well as other scientific communications initiatives.
- Contribute to the development of the global publications plan for designated products and support the optimal execution of the 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 medical affairs, with a focus on outcomes meaningful to payers and clinical decision-makers, including Pricing and HTA.
- Participate in the 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.
- Develop an 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 (e.g., AbbVie GK) and the development of functional charters from the Japan Medical Affairs perspective.
- Contribute as requested to the development/editing of other important medical communications to support 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 of 3-5 years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry.
- Experience in clinical trial design and conduct (Phases I, II, 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).
- Valid permanent residency in Japan.
- Native-level Japanese in verbal, reading, and 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。