Shire Global Medical Lead Hematology in Cambridge, Massachusetts

GML Hematology, focus on Hema A&B in US

  • Work with the Global Medical Team Lead (GMTL), Hematology, 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, Hematology 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

% of Time

Job Function and Description

20

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

40

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

30

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

10

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 Requirements

  • A medical degree is required

  • 10-14 years of experience

  • 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

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 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

  • 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 Global Medical Team Lead, GI

  • Internal: Member Global Medical Team, GI

  • Internal: US Medical Science Liaison Lead and Team, International Medical Affairs team, Shared Service teams, Regulatory, Compliance, Legal, Product Strategy Team

  • External: Academic, professional, regulatory, policy, patient advocacy leaders, strategic vendor partner

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Reasonable Accommodations

Shire 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.