Medical Affairs

The (Senior) Medical Director, Italy will serve as the foundational medical leader for Rett syndrome in Italy, responsible for designing and executing the full pre-launch and launch medical strategy for a first commercial product, in close collaboration with the country medical staff and aligned with Regional medical strategy. This role combines strategic leadership with hands‑on execution, requiring comfort operating with limited infrastructure, evolving processes, and high ambiguity.

The position will act as the primary medical interface to Italian healthcare professionals (HCPs), key opinion leaders (KOLs), and patient advocacy groups (PAGs), while increasing the company’s medical presence and credibility.

• Develop and own the Italian medical strategy for Rett syndrome from pre‑launch through launch and post‑launch, including budget responsibilities.
• Align European scientific vision and strategy into practical, locally relevant medical plans aligned with Italian clinical practice and patient pathways.
• Act as the single-country medical authority for Rett syndrome, representing the company externally and internally, together with the country medical affairs team.

• Design and execute disease‑education and unmet‑need initiatives ahead of national product approval aligned with launch readiness plan.
• Lead medical launch readiness, including scientific narratives, medical materials, and internal training, aligned with cross‑functional launch readiness plan in collaboration EU Regional medical team and local cross‑functional team.
• Partner closely with Commercial, Market Access, Compliance, and Regulatory colleagues to ensure a cohesive, compliant launch.

• Further develop Italy-wide KOL networks and expert centres, and multidisciplinary Rett syndrome care teams, aligned with cross‑functional engagement plan.
• Lead high‑impact scientific exchange, at medical conferences, advisory boards, and expert meetings, often acting as the primary scientific presenter.
• Support congress planning, abstracts, and publications relevant to Rett syndrome.

• Increase established trusted, long‑term partnerships with Italian Rett syndrome patient and caregiver organizations.
• Integrate the patient and caregiver perspective into medical strategy, education, and evidence generation.
• Collaborate ethically with PAGs on disease awareness, diagnostic journeys, and unmet needs, in line with Italian and EU compliance standards.

• Contribute to the design and execution of real‑world evidence, registries, and post‑marketing studies in Italy, including Investigator Initiated Studies (IISs).
• Support publication strategy and scientific communication activities.
• Help establish medical governance, SOPs, and compliant ways of working in Italy, appropriate for a growing biotech organization.

• Act as a key medical thought partner to GM and cross functional team, and senior leadership on scientific, clinical, and patient‑centric decisions related to Italy.
• Support build‑out of the Italian medical function, including future hiring, vendor selection, and process development, as needed.
• Be an active member of local leadership team.

• MD, Pharm
  
  D, PhD, or equivalent advanced degree in life sciences.
• Background in neurology, paediatric neurology, neurodevelopmental disorders, or rare diseases strongly preferred.

• 8–10+ years in Medical Affairs, Patient Advocacy, or related roles within biotech or (smaller) pharmaceutical companies.
• Experience in pre‑launch and launch medical activities, ideally in a first‑in‑class or early‑stage product environment, is a strong plus.
• Strong experience in rare diseases and/or neurodevelopmental disorders.
• Demonstrated ability to work independently, entrepreneurially, and cross‑functionally in a lean organization.
• Deep understanding of the Italian healthcare system, reference centres, and national rare disease networks.

• Highly hands‑on, adaptable, and…