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Vice President, Medical Affairs, EMEA
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Summary of Position:
Reporting to the SVP GM EMEA, the VP Medical Affairs EMEA will lead and oversee the company's medical affairs strategy and activities across the EUR region and will be the "go to" medical person in EMEA for internal and external stakeholders. This role will be responsible for driving the EUR region medical strategy and excellence, supporting evidence generation activities, ensuring scientific communication, and fostering relationships with key opinion leaders (KOLs), and healthcare professionals (HCPs). Working in a multifunctional, matrix organization with Global and US teams, you will ensure medical activities in the EUR region are aligned with overarching global strategies, goals and operations, as well as provide guidance and support to commercial and market access colleagues. You will play a crucial role in shaping the company's medical footprint in the EUR region and ensuring alignment with regulatory, national payers, and healthcare organizations. Position Responsibilities:
- Serve as the EUR Responsible Scientific Officer
- Lead the development and execution of the EMEA medical affairs strategy in alignment with global objectives
- Provide medical insights to support business and regulatory decisions
- Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, commercial, and market access) to ensure scientific alignment and strategic focus.
- Collaborate to develop medical strategy and content as appropriate for congresses, symposia and advisory boards and facilitate and execute such activities in Europe
- Ensure the dissemination of accurate, balanced, and scientifically sound medical information
- Lead the development and approval of region-specific scientific publications, presentations, and other communication materials
- Delivers scientific presentations to diverse audiences (e.g. physicians, pharmacists, marketing/medical agencies, and other key stakeholders) in meetings, advisory and/or consulting settings
- Represent the company at key scientific and medical conferences and engage with external stakeholders
- Develop and maintain relationships with top regional KOLs, HCPs, and patient advocacy groups across Europe
- Engage in meaningful dialogue with external experts to gather insights, feedback, and strengthen partnerships
- Support the co-development and sign off of promotional materials and campaigns, in the prelaunch and the launch phase and set up appropriate medical review procedure to make such materials compliant in EUR
- Indirect leadership to country medical affairs leaders
- Provide medical support to clinical development and clinical research conducted in Europe such as the identification of medical centers of excellence and key investigators/sites in such programs, support operational tasks such as investigator meetings and targeted patient recruitment efforts
- Continuously maintain deep scientific and medical knowledge of Spinal Muscular Atrophy and a deep understanding of patient and physician interactions and clinical decision making and impact
- Assess medical education needs in Europe and develop internal and external educational strategy as needed
- Provide EU region medical monitoring support for all clinical programs where needed
- Coordinate investigator-initiated studies and foster collaboration with academic institutions
- Ensure that all medical affairs activities are conducted in compliance with regional regulatory requirements, ethical guidelines, and company policies
- Support regulatory submissions, product launches, and post-marketing surveillance activities
- Lead and mentor a team of medical affairs professionals across the region
- Foster a culture of continuous learning and development within the medical affairs team
- MD (or equivalent), PhD, or PharmD required. Expertise in SMA is a plus
- Minimum total of 10 years of experience in medical affairs and/or clinical development
- Extensive experience in the biotech or pharmaceutical industry, particularly in rare diseases, and/or neurology (neuromuscular experience is a plus)
- Excellent communication (both verbal and written), presentation, and relationship-building skills
- Proven track record of successfully leading medical affairs strategies and teams and/or clinical studies at a regional level
- Strong knowledge of the European healthcare landscape, regulatory environment, and market access challenges
- Ability to interact with and build effective professional relationships with colleagues across functional areas. Demonstrate an exemplary ability to develop and maintain relationships with external colleagues, partners/ stakeholders
- Experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results
- Ability to work effectively in a fast paced, innovative and rapidly changing environment, while remaining flexible, proactive, resourceful and efficient
- Outstanding work ethic and integrity, including high ethical and scientific standards
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills
- Fluency in English; proficiency in additional European languages is an asset
- Ability to travel across Europe as needed.
