Position Purpose

The Respiratory Lead is a senior medical leadership role within Japan Specialty Care Medical Affairs, accountable for shaping and executing the local medical strategy for the respiratory pipeline portfolio in Japan.

The role acts as the Japan medical leader for respiratory pipeline assets from early development and Phase 3 readiness through to pre-launch and launch, leveraging deep pulmonology expertise to serve as the local scientific authority and strategic partner to global and regional teams, to proactively shape the disease and treatment paradigm in COPD and asthma through credible scientific engagement with Japan's respiratory community and health authorities, and to establish the company as a trusted scientific partner in the evolving Japanese respiratory treatment landscape and healthcare system.

The Respiratory Lead will provide medical and scientific leadership across the lifecycle of respiratory assets, leading the development of medical strategies and plans, generating evidence, building strong scientific relationships with leading respiratory clinicians and academic centers in Japan, and partnering closely with Development Japan (DJ), Global Development, Global Medical, and cross-functional teams to ensure Japan readiness for high-quality Phase 3 execution and successful launch.

This is a medical leadership role that combines clinical depth in respiratory medicine, scientific leadership across the pipeline, and matrix leadership of Medical Affairs Scientists (MAS) and cross-functional teams.

Key Responsibilities

1. Medical Leadership for the Respiratory pipeline portfolio in Japan (COPD & Asthma)

• Lead the development and execution of Japan medical strategy and the Medical Plan for the respiratory pipeline portfolio in Japan, with primary focus on COPD and Asthma and emerging pulmonology indications, in close alignment with global medical and development strategy.
• Provide deep medical and scientific expertise across the lifecycle from preclinical and early development through Phase 3, pre-launch, launch, and post-launch ensuring Japan readiness and meaningful Japanese contribution to global programs.
• Identify unmet medical needs (UMRs), healthcare disparities, and data gaps in COPD and asthma, and shape the medical activity plan accordingly.
• Contribute medically to lifecycle management, regulatory readiness, the Japanese healthcare and reimbursement environment, value-evidence planning, access and value strategy, and dossier development for respiratory pipeline assets.

2. Scientific Leadership and KOL Engagement

• Build and sustain robust, peer-to-peer scientific relationships with Japan's leading pulmonologists, respiratory KOLs, principal investigators, academic respiratory centers, and respiratory medical societies in COPD and asthma.
• Lead non-promotional scientific exchange, advisory boards, and educational engagements to deepen scientific dialogue on the evolving respiratory landscape and emerging mechanisms of action, including multispecific and novel biologic modalities.
• Maintain a comprehensive respiratory stakeholder map and lead the development and execution of structured engagement plans.
• Generate, collect, and analyze medical insights, translating them into actionable input for global and local strategy, including PMDA-relevant perspectives.

3. Collaboration with Development Japan (DJ) and Global Development

• Partner closely with DJ and Global Development on protocol feasibility assessments, principal investigator (PI) and site strategy, feasibility of Japan participation in global trials, and operational readiness.
• Provide strategic medical input into global clinical programs to ensure relevance to Japanese clinical practice, regulatory expectations, and patient populations.
• Support DJ in scientific and regulatory interactions with PMDA from early development phases, including input into clinical overviews, risk management plans (J-RMP), license variations, and CDS updates.
• Support the timely completion of company-sponsored clinical trials in Japan, contributing to high-quality, on-time delivery.

4. Evidence Generation and Scientific Dissemination

• Lead the planning and execution of evidence-generation activities for the respiratory pipeline, including real-world evidence (RWE), non-interventional studies (NIS), database studies, outcomes research, registries, and post-hoc analyses, in alignment with the integrated evidence plan.
• Oversee investigator-sponsored research and medical grants in the respiratory therapeutic area in accordance with company policy and applicable regulations.
• Ensure timely scientific publications and high-quality congress presentations to disseminate evidence relevant to the Japanese clinical and regulatory environment.

5. Customer-Facing Medical Activities and Insight Generation

• Lead the customer-facing component of the Medical Plan, ensuring high-quality, unbiased, scientifically rigorous engagement with healthcare professionals, respiratory medical societies, health authorities, and academia in respiratory medicine.
• Ensure all customer-facing medical activities, including advisory boards, educational seminars, scientific communications, and data dissemination, are conducted in a non-promotional, compliant manner.
• Lead the collection and strategic use of medical insights from Japanese respiratory KOLs and PIs to inform global and local strategy.
• Ensure patient-centricity of medical communications, incorporating health literacy and cultural awareness.

  Environmental Shaping and Japanese Healthcare System Engagement

• Proactively shape the disease and treatment paradigm in COPD, asthma, and emerging pulmonology indications in Japan through credible scientific exchange, medical education, evidence dissemination, and partnership with respiratory medical societies and academic centers.
• Anticipate and interpret the evolution of the Japanese healthcare system including diagnostic pathways, clinical practice guidelines, treatment standards, and the reimbursement framework and translate implications into the respiratory medical strategy and lifecycle planning.
• Provide medical and scientific input into Japan reimbursement and access strategy including contribution to value dossiers, evidence requirements for early benefit assessment, and scientific support to interactions with health authorities.
• Contribute medically to shaping the diagnosis and patient-journey paradigm in COPD and asthma in Japan, including identification of unmet diagnostic and care-pathway needs that may benefit from collaborative evidence generation or educational initiatives.

7. Cross-Functional and Internal Collaboration

• Partner with Marketing, Sales, Access & Value, Patient Advocacy, Safety, Medical Information, Regulatory, and Quality teams to deliver integrated, scientifically grounded brand and disease strategies for respiratory assets.
• Contribute scientifically and provide medical input to early benefit assessments, HTA submissions, pricing and reimbursement strategy, and value dossiers from a respiratory medical perspective.
• Provide scientific support and approval of promotional materials as required, within defined Medical Affairs governance and compliance boundaries.
• Actively participate in regional and global disease-area strategy teams for COPD, asthma, and broader respiratory portfolio decisions.

8. Matrix and Team Leadership

• Provide matrix leadership to Medical Affairs Scientists (MAS) and cross-functional partners working on the respiratory pipeline, fostering an inclusive, collaborative, and high-performance environment.
• Guide, coach, and develop team members through scientific mentoring, feedback, and growth opportunities.
• Lead achievement of team and departmental goals, with accountability for results across cross-functional projects.

9. Financial Accountability

• Support the preparation, planning, and management of the respiratory medical budget, coordinating with Country Medical Director (CMD) and internal departments.
• Ensure responsible stewardship of medical resources and budget accountability across the respiratory team.

10. Compliance and Safety

• Ensure all activities are conducted in full compliance with applicable codes of conduct (including JPMA Code), MHLW guidelines, company SOPs, and relevant regulations.
• Ensure adherence to pharmacovigilance and safety reporting obligations, and completion of required training.
• Penetrate the value of Medical Affairs both internally and externally while consistently adhering to the highest ethical and compliance standards.

As Needed

• Contribute to business development assessments by identifying unmet medical needs and evaluating candidate therapies in respiratory medicine while maintaining confidentiality.
• Lead rapid medical response in the event of critical supply, safety, or quality issues affecting respiratory products.

Required Qualifications

Education

• MD is required.
• Board-certified or clinically trained pulmonologist / respiratory physician strongly preferred.
• PhD or formal clinical research training is a plus.

Clinical and Therapeutic Area Experience

• Clinical practice or clinical research experience in COPD and/or Asthma is required.
• Familiarity with the evolving treatment landscape in respiratory medicine, including biologics and emerging modalities, is highly valued.
• Experience with severe asthma, eosinophilic disease, and/or chronic respiratory inflammation is an advantage.

Industry Experience

• Experience in Medical Affairs and/or Clinical Development within the pharmaceutical or biotech industry is strongly preferred.
• Experience supporting pipeline assets, pre-launch programs, and/or Phase 3 clinical development is strongly preferred.
• Experience contributing to scientific publications as first author and presenting at congresses is preferred.
• Experience in MSL or field medical roles is advantageous.
• People management, matrix leadership, or team leadership experience preferred.

Scientific and Medical Expertise

• Demonstrated expertise in medical strategy development across pipeline, pre-launch, and lifecycle phases.
• Strong understanding of drug development, the Japanese regulatory and reimbursement environment. and post-marketing activities in Japan.
• Strong knowledge of compliance frameworks, SOPs, and applicable codes of conduct.

Skills and Competencies

• Strategic Thinking and Scientific Leadership, translates complex science into clear strategy and engages confidently with senior internal and external stakeholders.
• Scientific Communication and KOL Engagement, exceptional ability to engage respiratory KOLs, PIs, and academic societies through credible peer-to-peer scientific exchange.
• Healthcare System and Environmental Shaping Acumen, ability to interpret the healthcare and reimbursement environment and proactively shape the disease and treatment paradigm through credible scientific partnership.
• Leadership and Influence, leads through influence in a matrix environment; fosters inclusive collaboration.
• Project Management and Business Acumen, manages complex, multi-stakeholder pipeline initiatives with rigor and accountability.
• Judgment, Integrity, and Patient-Centricity, exercises sound scientific judgment with the highest standards of integrity and a clear patient-focus.
• Coaching, Teamwork, and Problem-Solving, develops talent and resolves complex cross-functional challenges.

Language

• Fluency in Japanese and English required.
• Ability to read scientific papers in English, exchange English correspondence with global medical teams, develop English-language protocols and reports, and effectively participate in global teleconferences.
• Minimum TOEIC score of 730 (850 or higher preferred).

Organizational Relationships

Internal Partners

Specialty Care Medical Affairs team (including MAS and Therapeutic Area Leads), Development Japan (Clinical Research, Regulatory, Biostatistics, PMS), Global Development, Global Medical, Marketing, Sales, Access & Value, Health Economics & Outcomes Research (HEOR), Patient Advocacy, Safety, Medical Information, Business Development, Quality, Compliance, and Corporate Affairs.

External Partners

Respiratory KOLs and opinion leaders, principal investigators, pulmonologists and allied healthcare professionals (including nurses, pharmacists, respiratory therapists), academic medical centers, Japanese health authorities (including PMDA, MHLW), respiratory medical societies, patient advocacy groups in respiratory disease, pharmaceutical industry associations (JPMA, PhRMA, etc.), and external research and outsourcing partners.

Work Arrangement

• Work Location Assignment: Hybrid
• Worker Type: Regular
• Job Type: Full-time

Compliance Statement

All activities undertaken in this role must fully comply with the JPMA Code, applicable MHLW and PMDA guidelines, company SOPs, and the Medical Affairs Code of Conduct. The Respiratory Lead is expected to consistently demonstrate the highest standards of scientific integrity, ethical conduct, patient-centricity, and compliance, and to champion these standards across the team and cross-functional partners.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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