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Job Description

About the Role:

Plasma Derived Therapies Business Unit Research and Development (PDT R&D) group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases.

The Medical Director – Immunodeficiency leads and drives strategy for the overall global (US/EU/Japan/other regions and countries) clinical development for assigned Takeda pipeline compounds in Immunodeficiency. The candidate will apply their clinical expertise development, taking into consideration the medical, scientific, regulatory and commercial

perspectives.

How you will contribute:

• Leads clinical development for a given product and/or indication and may represent Clinical Science on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.

• Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols.

• Responsible for high impact global decisions with respect to Immunodeficiency: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development.

• Synopsis / Protocol Development, Study Execution, & Study Interpretation: drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists.

• Trial Medical Monitoring: responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.

• External Interactions: directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D.

• Due Diligence, Business Development and Alliance Projects: Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation. of clinical development plans for potential alliances and or in-licensing opportunities and serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D’s strategic goals.

• Leadership, Task Force Participation, Upper Management Accountability: interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. May also hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities

In this position you will report to the Head of Primary Immunodeficiency Clinical Science.

What you bring to Takeda:

• M.D. or internationally recognized equivalent degree is required. Additional advanced degree, e.g. Ph.D. is desired.

• Clinical Immunologist or Allergy / Immunology Specialist or Internal Medicine Specialist is preferred.

• 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.

• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions is desired.

• NDA/MAA Submission experience is preferred.

• Knowledge/experience in Immunology, or a related specialty, disease mechanisms and plasma derived/related therapies.

• Regional/global Regulatory requirements.

• Management experience is preferred.

• Superior communication, strategic, interpersonal and negotiating skills

• Ability to proactively predict issues and solve problems