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Job Description:

The Senior Director of Medical Affairs will hold a key leadership role within the operating company, focusing on the support and strategy development for multiple products. Reporting directly to the VP of Medical Affairs Japan and being part of the Medical Affairs Leadership Team, this position requires expertise in medical strategy and oversight of Therapy Area/Disease Area (TA/DA) Leads. The Senior Director will ensure the execution of medical and scientific activities, identify and address strategic gaps through collaboration with various departments, and engage with internal and external stakeholders. Additionally, the role involves managing the Medical Affairs strategy for therapeutic areas, overseeing budget and personnel, and ensuring compliance with relevant regulations. This position is based in Tokyo, Japan.

• The Senior Director, Medical Affairs will lead TA/DA Leads to supervise and ensure the smooth execution of all the medical and scientific activities including medical education event, digital projects as well as digital content maintenance.
• The Senior Director, Medical Affairs will identify and devise strategies to address crucial gaps using critical relationships across Medical Affairs, Regional & Global Medical Affairs, R& D, Business Units, IMAT, and others. He/she will lead and effectively partner with relevant Alliance partner companies on those activities.
• Responsible and accountable for Medical Affairs strategy of therapeutic area (TA) including compounds/product development/business plans.
• Collaborates with internal and external stakeholders including key opinion leaders and patient associations to develop and implement the overall Medical Affairs strategy for new and developing products aligned with company brand strategy.
• Elevates needs for funding to MA VP and Janssen Japan Management Committee
• Oversees development and implementation of Advisory Board strategy and maintain relationships with external investigators and opinion leaders.
• Ensures development of publications arising from Medical Affairs studies and works with relevant teams on broader communication strategy.
• Responsible for people management and operational budget management of TA departments.
• Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC rules.

Major Duties & Responsibilities / 職務および職責

• Develop and implement medical strategy
• Partner with key internal and external experts on identifying scientific gaps and data generation / communication opportunities.
• Supervise and mentor team as well as hiring
• Develop and implement broad MA strategy as a member of MALT

Other Duties

Developing TA strategy aligned with other critical functions/regions (R& D/BU/AP/GL):

• Supervision of Medical Affairs Plan (MAP)
• Assigning members for product development teams (JCoT).
• Provides input into brand strategy to BU and IMAT.
• Leading and supervising entire TA activities by providing clinical direction and strong leadership
• Accountability and supervision of of MAP and monthly report by products.
• Accountable for supervision and execution of all TAs’ activities
• Collaborates with functional directors to improve the functional excellence and alignment

Develop close relationship with Thought Leaders in the TA (KOL Management)

• Supervising KOL management plans for MSLs; and co-creating KOL management strategies with in collaboration with R& D/BU/IAMT
• Maintains strong scientific collaborations with thought leaders to efficiently collect medical needs.

Leading members in TA departments

• Accomplishing TA objectives by establishing plans and KPI measurements with functional directors.
• Managing operational budget and allocating human resources upon Medical Affairs plan
• Establishing good relationship with internal stakeholders (BU/R& D/AP; group level, individual issues or task oriented)

Key Requirements (skills, competencies, experience, certification) / 必要要件（スキル、知識、経験、資格）

Other: Relevant experience in pharmaceutical/biotech industry in medical affairs or clinical development, with strong medical focus and experience, related clinical knowledge or experience, medical strategy, publications, educational grants, and data generation, or equivalent academic or clinical experience.

Required Years of Related Experience:

10 years, at least 5 years in relevant position in pharmaceutical industry or relevant industries. Work experience of 2-3 years as a people manager in MA, R& D, and MKT of pharmaceutical industry.

Preferred Knowledge, Skills and Abilities:

MD, Relevant experience in pharmaceutical/biotech industry in medical affairs or clinical development.