About This Role

In line with the Biogen Biosimilar strategy, the Biosimilars Executive Medical Director will build and establish the Biosimilars US medical organization. You will set and provide the strategic direction for Biogen Biosimilars Medical Affairs in the US market for the whole Biosimilar portfolio. You will have an overall responsibility for the full scope of the country medical activities, including scientific communication, post marketing observational studies, medical education, medical field coverage, patient support programs, pharmacovigilance, drug safety and medical compliance for all Biosimilar products within the country. You will ensure execution of the strategy and build and maintain trusted medical/scientific relationships with healthcare stakeholders in the territory of major Biogen biosimilar strategic focus. In addition, you will build and recruit a team that will support and enable the US organization for the launch of the Biosimilar products and for the end-to-end medical activities. 

What You’ll Do

• Build the US Biosimilar medical team, define the needed functional and field resources, develop the business plan to justify the resource need and partner with HR during the hiring process
• Identify top external experts and develop strong peer-to-peer scientific partnerships with them, leading external expert coordination strategies within local/regional/global medical teams
• Develop the strategy for the US Medical Biosimilars organization, in conjunction with other internal functions
• Support the expansion of the Biogen Biosimilars Unit (BBU) with a wider range of pipeline assets in a wider range of therapeutic areas
• Support our development plans both strategically and operationally via supporting the execution of future registrational clinical studies in US and managing the interactions with FDA
• Partner with RA in supporting ongoing regulatory strategies for registration of new products and a life cycle management of the commercialized products.
• Build high value-added continuous medical educational programs for external stakeholders
• Developing and executing phase IVs, registries, etc. (master real-life medicine) in accordance with the local regulations and the global data generation strategies
• Develop and execute the patient support program for different products
• Provide medical perspective and knowledge to other teams within the Biosimilar team and the US organization as appropriate
• Ensure compliance with external laws and internal regulations regarding the appropriate conduct of the Biosimilars US Medical Affairs activities
• Aligned (global/regional/local and cross-functional) affiliate medical strategies for all products

 Who You Are

You are a proven leader within the Medical Affairs Biosimilars space and strive on developing, executing and advancing a national strategy. You implemented and managed high performing teams who excelled under your guidance.

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Required Skills and Education:

• MD and/or a PhD
• Ideally, a minimum of 10 years’ line management experience
• Minimum 12 years’ experience within a medical affairs role in the pharmaceutical industry (prior experience in ophthalmology; experience in at least one of the following is a plus: immunology / rheumatology / gastroenterology / dermatology)
• Knowledge and understanding of disease area, the US healthcare system/market dynamics, regulations, policies and SOPs, health economic techniques and trends
• Considerable experience in interaction with health authorities and medical plans/insurances
• Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments
• Demonstrated ability to build a team and develop a high performing organization
• Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job-level education

US Biogen Biosimilars (US BBU) is seeking great talent to help shape the future of healthcare in the US.  If you are a strong leader of innovation, business strategy & execution and people with a diverse medical background and a track record of success in healthcare delivery, we are looking for you.  US Biogen Biosimilars is committed to commercialization in several biologic categories and product launches.  With our first FDA application under current review with the FDA, we are a team committed to advancing care for patients needing life changing therapies.  As recent industry reports suggest, Biosimilar products in US healthcare have an opportunity to exceed $100 billion USD of savings during the next five years – Biogen is committed to be at the forefront of this opportunity for patients and the US healthcare system.