Global Medical Lead Early PipelineBKV

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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 toBKV / 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 platformaligned 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.0.13.0 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 Takedas 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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