Global Medical Lead - Director Medical Affairs - Physician
Shire - Lexington, MA

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Work with the Global Medical Team Lead (GMTL), IM, to develop and execute multi-year global medical strategy 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, IM, on the development and in-year implementation of the medical plan in the US and/or support in-year plan definition and implementation by International Medical Affairs

 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 :
Support definition of global medical strategy and plans:
  • Work with the GMTL and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • Support development of the in-year medical tactical plan and budget for the global initiatives and the United States
  • As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
  • As delegated by the GMTL, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution.
As delegated by the GMTL, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team

Work with GMTL on in-year implementation of global medical strategy as delegated by the GMTL, directly implement in plans in the US and/or guide International in-year implementation of medical strategy, potentially including:

  • Providing physician leadership for scientific communications, including standard responses and publications
  • Planning, designing and managing global and overseeing regional/local medical Advisory Boards
  • Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
  • Managing design and execution of clinical studies (phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
  • Managing completion of regulatory obligations
  • Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements
  • Conducting medical review and approval of promotional and meeting materials
Serving as Global Medical representative on standing and project-based cross-functional teams

Interaction with 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 / disease area

Maintenance of knowledge base

  • Serve as a key medical resource on the disease area and on specific products
  • 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 GMTL, develop, conduct, or participate in therapeutic training programs for Shire internal departments
Education and Experience:
 A medical degree is required

 >5 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.

 Experience in medical affairs is required

 Experience leading teams at the brand or disease area levels in country, regional or global organizations is preferred

 Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) is preferred

 Experience in clinical development is preferred

Experience in the disease area of interest through clinical experience, biopharmaceutical experience or education is preferred

Other Requirements:
 Availability to travel up to 50% of time

Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

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Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...