Posted to MedZilla on 11/22/2019

Takeda Pharmaceuticals

US-MA, Global Medical Lead - Transplant, Rare Specialty Care & New Programs SR0039287-MZ


Primary Duties

  • Work with the Global Medical Unit Head (GMU), Transplantation, Rare Specialty Care (RSC) & New Programs to develop and execute multi-year global medical strategy for the specified Product/Disease/Development areas, appropriately aligned with overall strategy and incorporating R&D functional strategies (Clinical, Regulatory, GOR/E, Global Drug Safety, Compliance)
  • Work with the GMU Head on the development and in-year implementation of the global medical plan and/or support in-year plan definition and implementation by Regional Medical Affairs (EUCAN-Europe/Canada, GEM-Global Emerging Markets, Japan, US)
  • Drives global execution of specific medical projects per global medical strategy
  • Serve as Global Medical representative on standing and project-based cross-functional teams
  • As needed, provide Medical review to Global promotional and non-promotional materials
  • Act as a company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
  • Establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest


50 %

Work with GMU Head on defining and implementing GMA strategy and prelaunch / launch / in-line product plans

  • Work with the GMU Head and Global Medical Team (GMT) to develop medical prelaunch and early access strategy, including e.g. publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area, aligned with overall product strategy
  • Support execution of the in-year medical tactical plan for the global initiatives
  • As delegated by the GMU Head, lead functional (e.g. publications, medical communications, medical training) and relevant R&D teams in developing plans supporting global medical prelaunch strategy
  • As delegated by the GMU Head, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution.
  • Supporting design and execution of clinical studies (phase IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Global Program Lead/Clinical Development Head/Global Clinical Development Lead and Global Clinical Operations
  • Serving as Global Medical representative on standing and project-based cross-functional teams


Interaction with internal and external stakeholders in alignment with customer needs and medical strategy

  • Act as a company representative with external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities
  • Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
  • Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest
  • Represent Medical Affairs at internal and external meetings
  • Present data on product / therapeutic area
  • Planning, designing and managing global medical Advisory Boards


Maintenance of Knowledge Base

  • Serve as a key medical resource on the disease area and on specific programs
  • Maintain a high level of expertise on the disease area
  • Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and Takeda policies related to all medical activities
  • As directed by the GMU Head, develop, conduct, or participate in therapeutic training programs for Takeda internal departments

Education and Experience Requirements

  • A medical or doctorate degree is preferred
  • >2-5 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.
  • Experience in medical affairs is required
  • Experience in (pre)launch activities is required
  • Experience working in cross-functional teams at the brand or disease area levels in country, regional or global organizations is preferred
  • Experience in the disease area of interest through clinical experience, biopharmaceutical experience or education is preferred

Key Skills, Abilities, and Competencies

  • Demonstrated business acumen and operational skills
  • Ability to think strategically and tactically from a medical perspective about how to medically appropriately support the launch and growth of a brand
  • Ability to work in a Global environment, across diverse cultures
  • Ability to collaborate appropriately with Commercial functions
  • Ability to represent company s interest in scientific forums as needed
  • Excellent written and verbal communication skills
  • Ability to manage teams and drive initiatives without direct line management authority
  • Results orientation and accountability
  • Good analytical skills as applied to medical, scientific and technical information
  • Unquestioned ethics are a must

Complexity and Problem Solving

  • Management of discrete medical projects and activities
  • Representation of GMA and contribution to a range of internal functional groups
  • External stakeholder management and engagement

Internal and External Contacts

  • Position is accountable to the Global Medical Unit Head, Transplantation, RSC & New Programs
  • Internal: Member Global Medical Team (Transplantation, RSC & New Programs)
  • Internal: US, EUCAN, GEM and Japan BU Medical Affairs Team including field based medical affairs, Shared Medical Excellence/Services teams, Regulatory, Compliance, Legal, Commercial
  • External: Academic, professional, regulatory, policy, patient advocacy leaders, strategic vendor partners

Other Job Requirements

  • Availability to travel approximately 30% of time
  • Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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