Head of Medical Affairs & Clinical Strategy USA

Location: United States (Remote with Travel) Acandis is expanding into the US market with its cutting-edge neurovascular technologies. We are seeking a Head of Medical Affairs USA to establish and lead our medical affairs strategy in the US. This senior role will focus Key Opinion Leader (KOL) Management, clinical evidence generation, and education to support the successful introduction and adoption of Acandis products in the neurovascular community. This is a high-impact, strategic leadership role, requiring a deep understanding of the neurovascular space, strong relationships with leading physicians, and the ability to align unmet clinical needs with Acandis’ product capabilities to drive adoption and market success. Key Responsibilities 1. KOL Engagement & Medical Strategy Development Proactively define and execute strategies for KOL engagement, anticipating emerging clinical trends and unmet needs. Identify, build, and maintain relationships with leading neurointerventionalists, stroke neurologists, and vascular neurosurgeons in the US. Collaborate with KOLs to define and refine product indications for the US, ensuring alignment with unmet clinical needs. Facilitate advisory boards, expert panels, and thought leader collaborations to guide Acandis’ US clinical and market strategy. Define and implement governance frameworks for Clinical Events Committee (CEC), Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB), including charter development and ongoing oversight. Drive early-stage physician engagement to generate clinical evidence and support real-world validation of Acandis products. Represent Acandis at key neurovascular conferences (SNIS, ISC, SVIN, etc.), shaping scientific dialogue and strengthening the company’s US presence. Discussion of diseases, treatment options, the state of clinical research, and the resulting study strategy on a fully equal footing with U.S. key opinion leaders (KOLs) and FDA reviewers Handling medical inquiries from physicians, hospitals, and other stakeholders regarding Acandis products. Acting as a bridge between R&D, clinical, & regulatory to ensure alignment of medical strategy with US market access roadmap. 2. Evidence Generation & Clinical Trial Strategy Lead the design and development of all US-based clinical trials , ensuring alignment with FDA and physician expectations. Work with KOLs and academic centers to identify key study endpoints and patient populations. Work closely together with the Acandis HQs Clinical and Medical Affairs team to utilize the existing knowledge and experience on clinical trials in Europe and to design US trials with OUS patient participation Oversee the collection and utilization of real-world evidence (RWE) and post-market data to support market expansion. Support physicians in developing scientific publications, white papers, and educational materials, providing guidance on study design, data interpretation, and manuscript preparation to drive clinical adoption. Participate in US site identification, engagement and activation strategy. 3. FDA Engagement Serve as the primary medical affairs liaison to the FDA, helping Regulatory and Clinical Affairs in shaping regulatory pathways and submission strategies. Provide clinical and scientific insights for regulatory interactions, ensuring trials and product indications meet US requirements. Lead discussions on clinical trial design, safety data, and unmet needs with regulatory bodies. 4. Physician Education and Adoption Leadership Define and lead the overall medical education strategy to support product adoption and clinical positioning Design and oversee medical education programs, KOL roundtables, and physician training initiatives to support safe and effective use of Acandis therapies. Provide direct clinical support to physicians during product adoption, including case discussions, and feedback on best practices. Serve as the strategic point of contact for complex clinical cases, guiding the team in real-time problem-solving and evidence-based recommendations. Required Qualifications & Experience: Bachelor’s degree required; advanced scientific, engineering, or other applicable degree (MS, PhD, MD preferred). 7+ years in medical affairs or clinical development with at least two years in the US neurovascular space Established relationships with US neurovascular KOLs, stroke centers, and leading academic institutions. Experience in formulating product indications, aligning clinical needs with device capabilities, and developing commercialization strategies. Strong understanding of neurovascular disease states, ICAD, flow diversion, and stroke treatment paradigms Demonstrated ability to learn quickly, with the ambition and capability to develop into a subject matter expert within the Acandis product portfolio. Proven track record of leading medical strategy and engaging with regulatory bodies (FDA, CMS, payers). Ability to work cross-functionally with regulatory, clinical, and commercial teams. Willingness to travel frequently within the US ~35% for Company meetings, KOL meetings, site visits, conferences, and regulatory engagements and infrequently for meeting at the Acandis HQ