US Medical Lead (USML) - is a member of the US Genetic Disease Medical Team. Working with the Head, US Genetic Disease Medical, the USML is to develop US strategies and execute US tactics for specified Product/Disease Area to ensure appropriate alignment with overall US business strategy
40%: Implementation in-year of US medical strategy with global alignment.
As delegated by the Head, US Genetic Disease Medical, directly implement plans in the US 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 for US
• 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 as designated by Head, US Genetic Disease Medical
• 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 US 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
20%: Support development of US medical strategy and plans with alignment with Global Medical Team.
• Work with Head, US Genetic Disease Medical and Global Franchise and Product Leads to develop US 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 US initiatives and where applicable, collaborate with Global initiatives
• As delegated by the US, Head Genetic Disease Medical, lead functional (e.g. publications, medical communications, medical information and medical training) plans supporting US medical strategy with alignment with Global where applicable.
• As delegated by the US, Head Genetic Disease Medical, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution
• As delegated by US, Head Genetic Disease Medical, participate in product development strategy and provide medical affairs and R&D inputs
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 Head, US Genetic Disease Medical and Global Franchise and Product Leads, develop, conduct, or participate in therapeutic training programs for Shire internal department
Education & Experience Requirements:
• A Doctor Degree in Medicine (MD), PhD, or PharmD is required.
• At least 4 years of combined experience working in industry, in clinical or research institution, preferably in Genetics, metabolic, or hematology
• >2 years of experience in biopharmaceutical industry, preferably within a matrix or franchise structure
• Experience in medical affairs particularly rare disease is preferred
• Experience in leading teams at the brand or disease area levels in country, regional or global organizations is preferred
• Experience in clinical development is preferred
• Experience in other relevant disease areas of interest through clinical experience, biopharmaceutical experience or education may be considered
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
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Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.