Head, Global Clinical Science & Medical Affairs for Marketed Products
TakedaAbout the role
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Job Description
OBJECTIVES/PURPOSE :
Provide global end-to-end medical and clinical science strategic leadership for marketed products, integrating post-approval clinical development, post-marketing commitments, and medical affairs into a single, cohesive strategy.
Ensure robust scientific, clinical, and medical oversight across the lifecycle of marketed products, safeguarding benefit–risk, patient safety, and regulatory compliance globally. Marketed Products portfolio comprised of 31 products with global activities split over 15 Global Program Teams and 80 established brands spanning multiple therapeutic areas.
Lead and develop a global organization of physicians, medical affairs leaders, and scientific directors, enabling high-quality scientific & medical strategy and planning, decision-making, execution, and talent development.
A senior medical and clinical leader for marketed products, partnering with R&D, Regulatory, Safety, Strategy & Portfolio Division, & Commercial Business Units.
Core member of the Marketed Products Medical & Development Leadership Team and chairs the Clinical Review Board for marketed products.
ACCOUNTABILITIES:
Accountable for global clinical science and medical affairs strategic oversight for a diverse and large portfolio of marketed products, spanning post-marketing clinical development, lifecycle management, as well as medical affairs activities for a defined portfolio of products.
Lead the global clinical science and medical affairs organization responsible for marketed products, ensuring scientific rigor, strong medical governance and robust strategic contributions to Global Program Teams (GPTs), Clinical Sub-teams (CSTs) and Medical Strategy Teams (MSTs)
Oversee clinical development plans, post-marketing commitments, Phase IIIb/IV studies, registries, and real-world evidence generation in alignment with product strategies.
Ensure benefit–risk assessments, safety evaluations, and clinical components of regulatory submissions are of the highest quality and aligned with global regulatory expectations.
Provide strategic leadership oversight for global medical affairs strategies, including scientific communications, publications, congress strategy, evidence generation, and external engagement.
Chairperson for Marketed Products Clinical Review Board and serves as a senior medical representative in scientific governance forums (e.g., Safety Board, labeling oversight, senior scientific committees).
Partner closely with Patient Safety & Pharmacovigilance, Regulatory Affairs, Clinical Operations, Statistics, Global Project Management, and Business Units, & Commercial to resolve complex scientific or strategic issues.
Ensure effective transition of assets from R&D Therapeutic Area Units and Global Medical Therapeutic Areas into Marketed Products Medical and Development maintaining continuity of scientific knowledge and business continuity.
Lead talent development, succession planning, and organizational capability building across global clinical sciences and medical affairs.
Represents the company externally with health authorities, key opinion leaders, patient advocacy groups, and scientific organizations, ensuring compliant and impactful engagement.
Collaborates with Legal, Compliance and Regulatory functions to ensure proper and ethical interactions between Marketed Products Medical & Development personnel and external stakeholders.
Ability to lead the application of AI tools, internal digital platforms and new technological skills to streamline processes, enhance quality & speed
EDUCATION, BEHAVIOURAL COMPETENCIES, AND SKILLS:
Required
MD required; PhD or equivalent advanced scientific degree strongly preferred.
Extensive experience in clinical development and medical affairs within the pharmaceutical or biotechnology industry.
Track record of successful leadership, management, and development of a globally dispersed team of clinical scientis
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