US Medical Affairs Lead (Director)
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POST DATE 8/10/2016
END DATE 11/30/2016
JOB DESCRIPTIONJob Description
Global Medical Lead (GML)- is a member of the Ophthalmic Global Medical Team. Working with the Global Team Lead (GMTL) the primary duty of GML is to develop and execute US and global medical strategy for specified Product/Disease Area to ensure appropriate alignment with overall business strategy.
20%: Support definition of global medical strategy and plans
Work with the GMTL and Global Medical Team (GMT) to develop global medical strategy that include scientific communication platform 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 the global initiatives.
As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical information and medical training) 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 product development strategy and provide medical affairs and R&D inputs
40%: Implementation in-year of US and global medical strategy
As delegated by the GMTL, directly implement plans in the US and/or guide
International in-year implementation of ex-US medical plans, potentially including:
Development and implementation of medical pre- and post launch plan for globally
Providing physician leadership for scientific communications, including standard responses and publications
Planning, designing and managing local, regional, national and global medical Advisory Boards
Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process as designated by GMTL
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 as requested
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 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 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 department
EDUCATION & EXPERIENCE REQUIREMENTS:
A Doctor Degree in Medicine (MD) is required.
Board certification in ophthalmology is preferred or at least 4 years experience working in industry or in research institution in ophthalmology or ophthalmology product/development candidate.
5 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.
Experience in medical affairs 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 the disease area of interest through clinical experience, biopharmaceutical experience or education is required
OTHER JOB REQUIREMENTS:
Domestic and international travel may be required for this position.
Approximately 5% travel is required.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.