Shire Global Medical Lead Hematology focus US Inhibitors & Blood disorders in Cambridge, Massachusetts

  • Focus on Inhibitors and blood disorders for US business

  • Work with the GMTL and other GMLs to develop and execute multi-year global medical strategy alignment 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, on the development and in-year implementation of the medical plan globally and/or support in-year plan definition and implementation by US GD TA team

  • Supports execution of specific medical projects per global medical strategy

  • Serve as Hematology Medical representative on standing and project-based cross-functional teams

  • As needed, provide Medical review to 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 development of global medical strategy and plans with alignment with Global Medical Team

  • Work with GMTL and Global Franchise and Product Leads to develop global medical plans that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre- and post- launch setting.

  • Support development of the in-year medical tactical plan and budget for respective products and initiatives

  • As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical information and medical training) plans supporting global medical strategy with alignment with Global where applicable.

  • As delegated by the GMTL collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution

  • As delegated by the GMTL, participate in product development strategy and provide medical affairs and R&D inputs

40

Implementation in-year of global medical strategy

As delegated by the GMTL, directly implement plans and collaborate with Global Franchise and Product Leads, potentially including:

  • Development and implementation of medical pre- and post- launch plans for late-stage pipeline products or product label expansions

  • Providing medical leadership for scientific communications, including core scientific statements, standard responses, Phase IV plans, and publications

  • Planning, designing and managing or participating in local, regional, national and global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval in RnD select

  • 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, HEOR studies, outcomes surveys, etc.) in close collaboration with Global Franchise and Product Leads, Scientific Affairs, Shared Medical Excellence and Clinical Operations

  • Managing completion of regulatory obligations (e.g. medical affairs input in safety review teams (SRTs).

  • Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements

  • Conducting and ensuring timely medical review and approval of promotional and meeting materials as required per SOP

  • Serving as Hematology Medical representative on standing and project-based cross-functional teams Serving as Global Medical representative on standing and project-based cross-functional teams

30

Effective compliant collaborations with internal stakeholders (R&D, commercial, marketing, regulatory, legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy

  • Act as a company medical representative to engage 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 at internal and external meetings

10

Maintenance of knowledge base

  • Serve as a key medical resource on the disease area and on specific product

  • Maintain a high level of expertise on the disease area

  • Develop and maintain knowledge of US and International pharmaceutical regulations, guidelines codes of practices and Shire policies related to all medical activities

  • As directed by the GMTL and Product Leads, develop, conduct, or participate in therapeutic training programs for Shire internal department

Education and Experience Requirements

  • A Doctor Degree in Medicine (MD), PhD, or PharmD is required.

  • 8-10 years of related work experience in industry, clinical or research institution, preferably in Genetics, metabolic, or hematology

  • Experience in medical affairs particularly Hematology is preferred

  • Experience in supporting brands or disease area levels in country, regional or global organizations is preferred

  • Experience in other relevant disease areas of interest through clinical experience, biopharmaceutical experience or education may be considered

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 mindset 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 GMTL, Hematology

  • Internal: Member Global hematology Team

  • Internal: Interactions with Global Medical Affairs team, Shared Service teams, Regulatory, Compliance, Legal, Product Strategy Team, commercial counterparts

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

Other Job Requirements

  • Availability to travel domestically and internationally as needed for approximately 20-30% of time

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

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.