Posted to MedZilla on 9/16/2019


Takeda Pharmaceuticals

US-MA, Global Medical Lead for Metachromatic Leukodystrophy SR0038379-MZ


 
 

Primary Duties

  • Work with the Senior Director, Global Medical Franchise Lead, to develop and execute multi-year global medical strategy and prelaunch plans for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
  • Work with the GMTL, Global Medical Team (GMT) and the Therapeutic Area Clinical Development head to develop medical prelaunch and early access strategy
  • Work with the Sr Director, Global Medical Franchise Lead, on the development and in-year implementation of the medical plan globally
  • Drive 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

Responsibilities

50% Collaborating with Global Medical Franchise Lead on defining and implementing GMA strategy, life cycle management and prelaunch plans

  • Work with the Global Medical Franchise Lead and medical sub team of the GPT to develop life cycle management and 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 Global Medical Franchise Lead, 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 Global Medical Franchise Lead, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution.
  • Support design and execution of clinical studies (phase IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
  • Be a medical monitor/lead in registries
  • Serve as Global Medical representative on standing and project-based cross-functional teams
  • Support LOCs on key local or regional projects

30% 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
  • Plan, design and manage global medical Advisory Boards

20% 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 Shire policies related to all medical activities
  • As directed by the Global Medical Franchise Lead, develop, conduct, or participate in therapeutic training programs for Tekeda internal departments

Education and Experience Requirements

  • A medical degree or equivalent is required
  • >5 years of experience in bio-pharmaceutical medicine, preferably within a matrix or franchise structure.
  • Experience in medical affairs 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, bio-pharmaceutical experience or education is preferred

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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