SVP, US Medical Affairs Lead

Role Summary:

The Head of Medical Affairs, U.S. is the medical leader responsible for the overall leadership & management of our medical affairs team in the U.S.. This role is a proactive strategic medical partner within the clinical, 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 U.S.. This role closely collaborates with the global medical affairs team to build an aligned U.S. medical affairs structure and facilitate the execution of the consolidated Global Medical strategic & tactical plan. In addition, this role ensures accurate, robust, and appropriate medical/scientific exchange of knowledge and clinical expertise with internal stakeholders across the U.S., and partners with relevant external stakeholders in driving success for preparing the launch.

This role is based in U.S. at the headquarters in Waltham, MA.

Primary Responsibilities Include:

• Works cross-functionally and especially closely with Global Medical Affairs, Clinical Development/Operations, and Commercial as well as to develop and execute the strategic medical affairs plans.
• Build and lead Field Medical Organization that faces Health Care Providers (HCPs) and U.S. Payers
• Maintains in-depth understanding of the Diseases state, product, competitors, marketplace, and related medical areas – included study design pre and post
• Build and lead an efficient and agile Medical Affairs strategy team to optimize the effectiveness of the strategy across this key market.
• Collaborate and partner effectively with internal stakeholders/business partners, both global and regional teams.
• Involvement in the scientific and medical communication strategy and in any non- promotional material review as per procedure. Once the MA is granted, 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
• Lead the strategy and key tactics for U.S. medical affairs, including but not limited to KOL and Payer advisory boards, symposia, conferences, real-world data collection, payer engagements, etc
• Support diseases related Investigator Initiated Studies (IIS) originating from the US 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 U.S. RWD, epidemiological, and /or observational studies to reinforce any evidence that can support regulatory and payer authorities.
• Oversee the medical component of the lifecycle
• Lead and implement a high level of medical integrity and health care
• Shape and optimize treatment paradigms, in collaboration with external and internal
• 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
• Define ambitious goals and establish priorities with clear responsibilities to ensure results; manages projects, activities and resources effectively.

 Education and Skills Requirements:

• MD, PhD, Pharm D or other relevant terminal
• Ideally has Neuromuscular Disease experience, and should have Rare Disease
• 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.
• Experience working with teams / individuals with varied cultural backgrounds and learning styles.
• Intermediate to advanced competency and experience with a variety 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 S. region and internationally at times.
• Fluent in English (required)
• Excellent team player, strong decision maker, and ability to work in a matrix
• 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