US Medical Affairs Lead (Director)
Lexington , Massachusetts
August 10, 2016
Primary Role:

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.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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