European Head of Medical Affairs

Role Summary

The Head of Medical Affairs, Europe is the medical leader responsible for the overall leadership & management of our medical affairs team in Europe. This role is a proactive strategic medical partner within the medical and eventually the commercial organization driving medical excellence and acting as a key member of the Global Medical Affairs organization as the point person in Europe.

This role closely collaborates with the global medical affairs team to build an aligned regional medical structure and facilitate the execution of the consolidated Global and Regional Medical tactic plans. In addition, this role ensures accurate, robust, and appropriate medical/scientific exchange of knowledge and clinical expertise with internal stakeholders across the region, and partners with relevant external stakeholders in driving success for preparing product launches in the region.

The person in this role is the regional Subject Matter Expert (SME) for the therapeutic area and the regional organization.

This role reports to the Global Head, Medical Affairs, is based in Europe and will travel to the Global Headquarters in Waltham, MA as needed.

Applicants must be based in Europe. 

Primary Responsibilities Include:

• Works cross-functionally and especially closely with Global Medical Affairs and Clinical Development/Operations as well as to develop and execute the operational medical affairs plan for the therapeutic area in the region
• Maintains in-depth understanding of the Diseases state, product, competitors, marketplace, and related medical areas – included study design pre and post approval
• Build and lead a small and agile Medical Affairs European team to optimize the effectiveness of the strategy across the countries
• Collaborate and partner effectively with internal stakeholders/business partners, both EU and Countries based in EU region
• Involvement in the scientific and medical communication strategy and in any non-promotional material review as per procedure until market authorization (MA) is granted. Once the MA is granted, he / she is responsible for the scientific review of any promotional material
• Deliver timely, fair balanced, objective, scientific and economic information, and education to health care customers and to internal business partners as required by business needs
• Lead the strategy and key tactics of European medical meetings (e.g., advisory boards, symposia, conferences, etc.)
• Actively contribute to the execution of the overall company strategy at regional level and countries scientific meetings by representing the medical team in any medical – scientific relevant meetings (e.g., KOL meetings)
• Support diseases related Investigator Sponsored Trials research studies originating from the region through review, submission, evaluation, and recommendation of concepts/ proposals via the company process
• Provide medical input into the disease models, market research lead by the Commercial and Market Access team
• Plan and lead regional HEOR, epidemiological, and /or observational studies to reinforce any evidence that can be incorporated in the market access and value dossier to prepare and maintained access to the product. Oversee the medical component of the lifecycle management
• Lead and implement a high level of medical integrity and health care compliance
• Shape and optimize treatment paradigms, in collaboration with external and internal stakeholders
• Think strategically to translate medical/clinical insights of treatment paradigms into growth opportunities, process improvement and driving competitive advantage
• Keen ability to make practical, realistic, fact-based, thoughtful, and timely decisions while building a collaborative culture
• Stimulate and motivate people and teams to develop and execute medical excellence and medical leadership
• Patient centric thinking, putting patient needs central in developing strategies to differentiate the value we bring to customers
• Identify opportunities and take action to build strong scientifically based relationships; able to gather and represent professional views, partners with customers and internal stakeholders
• Define ambitious goals and establish priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively

 Education and Skill Requirements:

• MD, PhD, Pharm D or other relevant terminal degree
• Ideally has neuromuscular disease experience, and should have Rare Disease experience
• Diverse background of professional experience including ten plus (10+) years of Medical Affairs experience plus clinical development/operations knowledge, with in depth knowledge of rare disease drug development, market access, commercialization, and life cycle management
• Previous experience interacting with Health Technology Assessment (HTA) bodies
• Experience working with teams / individuals with varied cultural backgrounds and learning styles
• Intermediate to advanced competency and experience with a variety of computer applications, including Microsoft Suite, MS Project, SharePoint and/or other related project management tools
• Strong interpersonal skills with the need to work closely with both external and internal business partners
• Willingness/ability to travel up to 30-50% in the European region and internationally at times
• Fluent in English (required). Additional European languages would be highly appreciated
• Excellent team player
• Strong decision maker
• Ability to work in a matrix environment
• Ability to work independently as a hands-on manager, and proactively contribute as a resource when necessary
• Flexibility to adapt and meet the changing/growing needs of our customers
• High level of integrity, compliance, ethics, and transparency
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