Global Medical Lead Early Pipeline/BKV

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Job Description

Role Purpose

TheSenior Director, Global Medical Lead (GML), PDT+ Pipelineis the strategic owner of theglobal medical strategyfor theBKV programand PDT+ pipeline developments (current focus includes, but is not limited to,BKV / Renal Transplant). This is a high-impact, enterprise-facing role spanningstrategy definition, evidence generation leadership, scientific platform oversight, global launch excellence, external influence, andmatrix leadershipacross regions, LOCs, and cross-functional partners.

Key Objectives

• Own and drive the multi-yearglobal medical strategyfor the BKV program and PDT+ pipeline product/disease area.

• Build global medical capacity for the relevant pipeline product/disease area, includingexpanded accessstrategy support.

• Serve as theglobal subject-matter expertwithin PDT+ and across functions for the pipeline product/disease area.

• Lead cross-functional alignment to deliver scientific excellence from early development through launch.

Key Accountabilities

• Lead the development and execution of amulti-year global medical strategyfor the pipeline product/disease area, including publications strategy, evidence generation, congress strategy, HCP interaction strategy, and the scientific communication platform—aligned with overall strategy and R&D functional strategies (clinical, regulatory, GEO, safety, compliance).

• Serve as theglobal Medical Affairs leaderfor the pipeline product/disease area and represent the asset at the enterprise level, contributing to portfolio strategy and long-range medical planning.

• Set medical strategic imperatives and ensure alignment withClinical Development, Regulatory, Market Access/HEOR, Commercial, and regional/LOC medical teams.

• Develop and execute theGlobal Medical Plan, including:

  • Scientific positioning

  • Scientific communications strategy

  • Evidence generation strategy

  • External engagement strategy

• Engage early withPharmaceutical SciencesandBusiness Developmentto identify and evaluate new assets.

• Lead and inspireMedical Strategy Teams, ensuring strong collaboration with regional and LOC partners (publications, medical communications, medical training, evidence generation).

• Provide strategic input to R&D and senior management within the PDT business unit; lead in a matrix across Medical Affairs and at GPT level as appropriate.

• Own the medical budget for the product/disease area (approx.0.1–3.0 Oku Yen).

Scientific Communications & Positioning

• Drive scientific positioning and lead pre-launch and launch scientific communications, including:

  • Publication strategy

  • Congress strategy and congress selection

  • Scientific platform

  • Medical Core Story

External Engagement

• Establish strategic partnerships with centers of excellence, key external experts/HCPs, scientific societies, and patient organizations (in collaboration with Patient Advocacy).

• Act as Takeda’s senior representative for relevant external audiences.

• Partner with Legal, Compliance, and Regulatory to ensure appropriate and ethical external interactions.

• Plan, design, and lead globalAdvisory Boardsas appropriate, including global speaker strategy.

Evidence Generation Leadership

• Lead theIntegrated Evidence Strategy, including:

  • Phase 3/4 and lifecycle clinical strategy

  • Real-world evidence planning

  • Registries and long-term extension programs

  • HTA/SAP, burden of illness, and comparative analyses

• Drive cross-functional evidence prioritization to support label, access, value narrative, and global differentiation.

• Ensure global rigor and excellence in data dissemination.

• Lead design and execution of Medical Affairs company-sponsored and collaborative studies (Phase IIIb/IV, registries, observational/non-interventional, epidemiology, outcomes surveys) in close collaboration with TAU representatives and Global Clinical Operations.

• Monitor progress against the medical plan and adapt initiatives as needed based on disease area requirements.

People & Capability Development

• Build global medical capabilities (e.g., medical training, analytics maturity, scientific communications excellence).

• Foster an enterprise mindset and culture of scientific excellence.

Qualifications

Required

• Advanced medical or scientific degree (MD, PharmD, or PhDpreferred), ideally with clinical experience inTransplant Medicine, Immunology, or Nephrology.

• Demonstrated experience across the scope of the role through Clinical/R&D/Medical Affairs work, with expertise inNephrology, Transplant, and/or Immunology.

• 11+ yearsin Medical Affairs and scientific leadership, with a strong track record in strategy development, product development, and launch strategy.

• Proven ability to lead cross-functional teams in amatrixenvironment.

Preferred

• Clinical experience in Nephrology and/or Transplantation.

• Field-based experience (e.g., Medical Director, Medical Science Liaison) a plus.

• Clinical development experience preferred.

Skills & Competencies

• Strong scientific acumen and understanding of clinical medicine

• Strategic thinking, proactive mindset, and execution focus

• Hands-on leadership, strong collaboration and influence skills

• Strong intercultural competence and commitment to global diversity

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