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
Requirements
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
communication skillspresentation skillsrelationship-buildingleadershipcollaborationflexibilityproactivityintegrityinterpersonal skillsanalytical skills