会社概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

Purpose Statement:
Leads a team in a therapeutic area, Immunology Gastroenterology (Inflammatory bowel diseases) in developing and executing the Medical strategy for an AbbVie asset in development or a market product. Responsible for practical and clinically meaningful evidence generation strategy and delivery to inform clinical use and transform standard of care. Deeply understanding the patient journey and apply insights into determining the unmet medical need. Provide strategic medical input into core brand strategies, and to support medical marketing activities and market access.

Major Responsibilities:

• Drives Immunology Gastroenterology strategies plans and life cycle management plan in line with the brand strategy and is a key internal contact/subject matter expert. Takes primary responsibility for all indications in Gastroenterology. Lead cross-functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
• Participates as a member of Japan Medical TA Management. Build, manage and develop Immunology Gastroenterology team by providing coaching, mentoring and training. Supervise 6-8 medical/scientific advisors and 8-15 MSLs, which may include other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of Japan Medical TA management. Assist in developing/mentoring medical affairs staff in other therapeutic area.
• Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy in Immunology Gastroenterology area. Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, statistics, regulatory, etc.) as they relate to on-going medical affairs projects in Immunology Gastroenterology area.
• Oversees scientific/medical education of investigators, clinical monitors, and related stakeholders related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information.
• Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within the therapeutic area. May represent the medical function on cross-functional integrated teams for medical affairs activities.
• Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad-hoc safety monitoring reports to regulatory agencies.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of area/global medical affairs sponsored or supported clinical research activities.
• Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.

資格

Qualifications:

• Medical Doctor (MD) or PhD degree within relevant therapeutic area is preferred.
• At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to perform and bring out the best in others on a cross-functional global team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
• Possess excellent oral and written Japanese and English communication skills.
• People management experience (more than 2 years)

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。