Evidence Generation Leadership

→Lead the development and execution of evidence-generation plans that address critical
→scientific, clinical, health economic, and market access evidence gaps across the product
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→Design and oversee Phase IIIb/IV studies, health economics and outcomes research (HEOR), real
→World evidence (RWE) studies, registries, database studies, and other post-marketing research
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→Ensure evidence-generation activities align with medical strategies and business priorities
→Through close collaboration with Therapeutic Area Medical Affairs, Market Access, and
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→Drive innovation in evidence generation methodologies to maximize the value and impact of scientific evidence.

Study Strategy, Design & Execution

→Provide leadership for study concept development, protocol design, feasibility assessments, and
→Oversee the execution of company-sponsored studies and ensure timely delivery of study milestones, high-quality data generation, and regulatory compliance.
→Support the scientific review and governance of Investigator-Initiated Studies (IISs) andcollaborative research projects.
→Monitor study progress, identify risks proactively, and implement mitigation strategies to ensure successful study completion.

Publication & Scientific Dissemination

→Lead the development and execution of integrated publication strategies aligned with evidence generation priorities and medical objectives.
→Oversee publication planning, manuscript development, abstracts, congress presentations, and scientific communication activities.
→Ensure scientific accuracy, transparency, quality, and compliance throughout the publicationdevelopment process.
→Facilitate timely dissemination of scientific evidence to healthcare professionals, academic communities, and other stakeholders.

Scientific Excellence & Insights Generation

→Monitor emerging scientific evidence, treatment trends, competitive developments, and evolving Generate actionable insights from clinical studies, real-world evidence, and healthcaredatabases to support medical and business decision-making.
→Collaborate with Office Medical Affairs, MSL, Market Access, and regional/global functions toidentify evidence needs and translate findings into strategic recommendations.
→Promote scientific excellence and methodological rigor across all evidence-generation activities.

Cross-functional Leadership & Collaboration

→Act as the primary evidence-generation representative within cross-functional teams and strategic initiatives.
→Partner closely with Office Medical Affairs, MSL, Market Access, Regulatory Affairs,Pharmacovigilance, Clinical Development, and regional/global Medical Affairs teams.
→Provide scientific and methodological expertise to support evidence-based decision-makingundefinedFoster strong collaboration with external investigators, study sites, academic institutions,contract research organizations (CROs), and other research partners.

Vendor, CRO & External Research Management

→Oversee the selection, management, and performance of CROs, research vendors, and externalpartners involved in evidence-generation activities.
→Ensure high-quality project delivery, budget adherence, contractual compliance, and effective resource utilization.
→Build and maintain productive relationships with external research collaborators and scientific organizations.

Budget Management

→Develop and manage evidence-generation and publication budgets in alignment with strategic priorities and organizational goals.
→Ensure efficient allocation of financial and operational resources across research and publication activities.
→Monitor budget performance and contribute to annual planning, forecasting, and investment discussions.
→Evaluate return on investment and strategic impact of evidence-generation initiatives to support future prioritization decisions.

People Leadership & Capability Development

→Foster expertise in epidemiology, outcomes research, medical writing, publication planning, and evidence-generation methodologies.
→Promote a culture of scientific excellence, collaboration, accountability, and continuous improvement.
→Build organizational capabilities to support future evidence-generation needs and strategic priorities.

Governance & Compliance

→Ensure all research and publication activities comply with applicable regulations, ethical tandards, company policies, GCP requirements, and industry guidelines.
→Maintain oversight of publication governance and scientific integrity processes.
→Ensure inspection and audit readiness for all evidence-generation activities.
→Promote transparency and responsible scientific communication in accordance with international publication standards.

Required Experience & Competences:

Minimum Education Requirements

→MD, Ph.D., or PharmD in a medical specialty or equivalent combination of experiences and education

Minimum Experience Requirements

→Min 2+ years of Medical experience in the TA from:
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→Experienced in formulating and executing clinical studies is preferred
→Able to understand complex scientific information and communicate this effectively
→Team player with the ability to work under their initiative with a high work capacity by balancing priorities
→Business fluency in English and Japanese

Data Generation & Publication Manager

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