Shire Product Medical Lead in Cambridge, Massachusetts
% of Time
Support development of US medical strategy and plans with alignment with Global Medical Team
Work with GMTL 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 GMTL 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 GMTL, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution
As delegated by US,GMTL, participate in product development strategy and provide medical affairs and R&D inputs
Implementation in-year of US medical strategy with global alignment
As delegated by the GMTL and IMM Franchise Head, 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 GMTL
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 Serving as Global Medical representative on standing and project-based cross-functional teams
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
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 Global Franchise,, Product Leads will 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.
At least 5 years of related work experience in industry, clinical or research institution, preferably in genetics, metabolic, pulmonary, hematology or AATD related experiences
Experience in medical affairs particularly rare disease 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
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
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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 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.
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/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.