(Senior) Medical Director, Italy

Rome - Italy

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

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 companys medical presence and credibility.

Key Responsibilities

Medical Strategy & Startup Leadership

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.

Pre-Launch & Launch Execution

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.

HCP & KOL Engagement

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.

Patient Advocacy Group (PAG) Engagement

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.

Evidence Generation & Medical Infrastructure

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.

Cross-Functional & External Leadership

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

Qualifications & Experience

Education

MD PharmD PhD or equivalent advanced degree in life sciences.
Background in neurology paediatric neurology neurodevelopmental disorders or rare diseases strongly preferred.

Experience

810 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.

Skills & Attributes

Highly hands-on adaptable and comfortable with ambiguity.
Strong scientific credibility and ability to influence without authority.
Excellent communication skills in Italian and English.
High ethical standards and strong understanding of medical compliance in Italy and the EU.

#LI-REMOTE

Required Experience:

Director