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Provide scientific leadership for the vaccine business in Japan. Develop and execute medical strategies—including launch, label expansion, and gap-filling—based on scientific integrity, patient value, and ethical/legal compliance. Lead approximately 20 Vaccine MA members, including first-line managers. Foster team development and cultivate scientific leaders capable of identifying unmet medical needs, planning and executing medical strategies, and generating clinical evidence. This role requires proactive leadership to drive cross-functional initiatives, ensure scientific excellence, and foster a high-performing team culture that delivers measurable impact in the dynamic vaccine and infectious disease landscape.
Job Responsibility:
Develop annual Medical Affairs Plans (MAPs) aligned with Japan’s infectious disease epidemiology, NIP (National Immunization Program), local implementation, and decision-making processes
Lead launch preparation and execution for new products, indications, and technologies
Identify unmet medical needs and healthcare disparities via advisory boards
create and drive action plans to address data gaps
Lead unbiased scientific communication, HCP education seminars, data generation initiatives, and development of scientific materials
Contribute to lifecycle planning for both inline and pipeline vaccines
Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science
Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation
Oversee publication and conference presentation plans
Support investigator-initiated studies and medical grants per internal policy
Map KOLs and next-generation leaders
strengthen scientific presence in societies
Plan and manage advisory boards
Lead scientific dialogue with public institutions (MHLW, PMDA, NIID)
Respond to Unsolicited Medical Requests (UMRs) with high-quality, unbiased information
Contribute to PMDA consultations and post-marketing activities
Provide clinical perspectives on label updates and risk minimization plans (RMP)
Ensure team compliance with safety reporting regulations and internal policies
Oversee scientific platforms (core slides, FAQs, educational materials, digital assets)
lead MLR review
Operate One-Voice strategy with Medical affairs scientist
Support brand planning by providing medical/scientific advice to marketing teams
Lead scientific input for academic meetings and medical education programs
Design and manage the Vaccines MA organization, including hiring, capability development, and succession planning
Develop and manage annual budgets
Foster a culture of DE&I and psychological safety
Lead people management through appropriate assignments, coaching, evaluations, and constructive feedback
Support clinical development programs and regulatory authority interactions
Provide internal and external medical/scientific advice to ensure appropriate vaccine use
Contribute to business development
Support medical response to supply issues
Requirements:
Advanced degree (MD, PharmD, PhD)
10+ years of Medical Affairs experience in vaccines/infectious diseases, including 7+ years of people leadership
Proven track record in national-level strategy development and execution for new product launches/indication expansions
Experience in scientific dialogue with PMDA, MHLW, municipalities, and academic societies (presentations, chairing, committee participation)
Practical understanding of Pharmaceutical Affairs Law, GCP, GPSP, GVP, Clinical Research Law, Personal Information Protection Law, JPMA Code
Deep expertise in vaccine-related Medical Affairs
Leadership: Inspire, develop, and lead teams in dynamic environments with scientific excellence
Communication and relationship-building skills across internal and external stakeholders
Compliance: Promote appropriate use through understanding of industry regulations
Learning agility: Ability to quickly self-learn necessary medical/scientific knowledge
Ability to read and converse in English (advanced business level)
Nice to have:
Knowledge of RWE, epidemiology, implementation science
experience in designing and managing observational studies
Extensive experience in MLR review, digital asset oversight, and advisory board planning
Participation in government/society working groups and involvement in white papers/recommendations