Lead the Vaccine Medical Affairs team to develop strategies for vaccine business in Japan, focus on team leadership, scientific communication, regulatory affairs, and external engagement with stakeholders.
VAC MA lead Job description
1. Position Overview
2. Key Responsibilities
The person in this role is expected to lead strategic planning and execution across the responsibilities outlined below, and to take full accountability for the outcomes.
A. Medical Strategy & Roadmap
B. Evidence Generation (RWE/Phase IV/Investigator-Initiated Studies)
C. External Engagement (KOLs, Societies, Policy)
D. Regulatory Affairs, Safety, and Appropriate Use
E. Scientific Communication / MLR / Internal Collaboration
F. Organization, Talent, and Budget
G. As Needed
3. Qualifications Required
Preferred
Language
4. Competencies
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
1. Position Overview
- Title: Senior Director, Vaccines Medical Affairs Lead, Japan
- Department: Medical Affairs (Vaccines)
- Location: Tokyo (Domestic and international travel required)
- Reporting Line: Country Medical Director, Japan
- Mission: 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.
- Team Leadership: 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.
2. Key Responsibilities
The person in this role is expected to lead strategic planning and execution across the responsibilities outlined below, and to take full accountability for the outcomes.
A. Medical Strategy & Roadmap
- 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 (e.g., mRNA), defining success criteria across evidence, education, policy, and implementation.
- 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, implementing local medical strategies and clinical plans.
B. Evidence Generation (RWE/Phase IV/Investigator-Initiated Studies)
- Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science. Conduct collaborative studies in compliance with clinical research law, ethical guidelines, GCP/GPSP/GVP.
- Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation.
- Oversee publication and conference presentation plans, ensuring transparency and COI management.
- Support investigator-initiated studies and medical grants per internal policy.
- Maintain high scientific standards across all internal and external activities to promote appropriate, effective, and safe vaccine use.
C. External Engagement (KOLs, Societies, Policy)
- Map KOLs and next-generation leaders; strengthen scientific presence in societies such as the Japanese Society of Infectious Diseases, Pediatrics, Vaccinology, and Public Health.
- Plan and manage advisory boards (objective setting, consensus building, insight utilization, documentation, COI/honorarium management).
- Lead scientific dialogue with public institutions (MHLW, PMDA, NIID), ensuring transparency and avoiding corporate bias.
- Build non-promotional relationships to establish long-term, trust-based collaborations.
- Respond to Unsolicited Medical Requests (UMRs) with high-quality, unbiased information and share insights internally.
- Continuously gather and integrate the latest medical/pharmaceutical knowledge to strengthen portfolio-related information infrastructure.
- Apply insights with a patient-centric approach, embedding health literacy and cultural sensitivity into materials and communications.
D. Regulatory Affairs, Safety, and Appropriate Use
- Contribute to PMDA consultations and post-marketing activities (e.g., usage surveys)
- Provide clinical perspectives on label updates and risk minimization plans (RMP); collaborate with PV on safety signal evaluations.
- Ensure team compliance with safety reporting regulations and internal policies; plan and complete necessary training.
E. Scientific Communication / MLR / Internal Collaboration
- Oversee scientific platforms (core slides, FAQs, educational materials, digital assets); lead MLR review and ensure compliance with JPMA code and Pharmaceutical Affairs Law.
- Operate One-Voice strategy with Medical affairs scientist to ensure scientific consistency and insight sharing.
- Support brand planning by providing medical/scientific advice to marketing teams.
- Lead scientific input for academic meetings and medicaleducation programs with societies and related organizations.
- Promote conduct and POJ (Principles of Operation in Japan) compliance in external Medical Affairs activities, clarifying promotional/non-promotional boundaries.
F. Organization, Talent, and Budget
- 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; drive change leadership in the dynamic vaccine/infectious disease space.
- Demonstrate leadership through collaboration with colleagues, internal stakeholders, and external customers to align with shared vision and strategy.
G. As Needed
- 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, including rapid communication with societies and authorities.
3. Qualifications Required
- 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.
Preferred
- 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.
- Academic publishing experience (scientific papers, conference presentations).
- Project management experience handling multiple concurrent projects.
Language
- Ability to read and converse in English (advanced business level)
4. Competencies
- Strategic thinking (integration of science, policy, and implementation); influence (drive decisions through science).
- Collaboration (value creation with Commercial, Market Access, Regulatory, PV, Clinical).
- Compliance & ethics; data literacy (RWE/statistics/epidemiology); talent development; change leadership.
- Change management: Lead transformation in evolving vaccine/infectious disease environments.
- Customer insight utilization: Reflect HCP/society/policy insights in strategy to enhance decision quality.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
Top Skills
Clinical Research Methodologies
Covid-19 Vaccines
Databases (Jmdc/Mdv/Ndb)
Mrna Technology
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