Senior Medical Director

This is a fully remote position, open to applicants in Italy.

📋 Description

• Develop and oversee the Italian medical strategy for Rett syndrome, encompassing all phases from pre-launch to post-launch, with budget management responsibilities.

• Align the European scientific vision and strategy with actionable, locally relevant medical plans that correspond with Italian clinical practices and patient pathways.

• Serve as the sole medical authority for Rett syndrome within Italy, representing the company both externally and internally alongside the country medical affairs and cross-functional team.

• Design and implement disease education and unmet medical need initiatives in preparation for national product approval, in line with the launch readiness plan.

• Lead medical launch preparations, including the creation of scientific narratives, medical materials, and internal training, ensuring alignment with the cross-functional launch readiness plan in collaboration with the EU Regional medical team and local cross-functional team.

• Collaborate closely with Commercial, Market Access, Compliance, and Regulatory teams to ensure a unified and compliant launch.

• Further cultivate nationwide KOL networks and expert centers, as well as multidisciplinary Rett syndrome care teams, in accordance with the cross-functional engagement plan.

• Together with country medical colleagues, spearhead impactful scientific exchanges at medical conferences, advisory boards, and expert meetings, often serving as the primary scientific presenter.

• Assist in congress planning, as well as in the development of abstracts and publications relevant to Rett syndrome.

• Foster and expand established, trusted long-term partnerships with Italian Rett syndrome patient and caregiver organizations alongside country medical staff.

• Incorporate the perspectives of patients and caregivers into the medical strategy, education, and evidence generation.

• Collaborate ethically with Patient Advocacy Groups (PAGs) on disease awareness, diagnostic pathways, and unmet needs, ensuring compliance with Italian and EU standards.

• Contribute to the design and implementation of real-world evidence, registries, and post-marketing studies in Italy, including Investigator Initiated Studies (IISs) as applicable.

• Support and lead national publication strategies and scientific communication efforts.

• Assist in establishing medical governance, SOPs, and compliant operational practices in Italy, suitable for a growing biotech organization.

• Act as a key medical strategic partner to the General Manager, cross-functional team, and senior leadership regarding scientific, clinical, and patient-centric medical decisions in Italy.

• Aid the development of the Italian medical function, including future hiring, vendor selection, and process development as necessary.

• Be an active participant in the local leadership team as well as the European Medical Team.

⛳️ Requirements

• MD, (PharmD, PhD) or an equivalent advanced degree in life sciences.

• A background in neurology, pediatric neurology, neurodevelopmental disorders, or rare diseases is highly preferred.

• Over 10 years of experience in Medical Affairs, Patient Advocacy, or related roles within biotech or smaller pharmaceutical companies.

• Proven experience in pre-launch and launch medical activities, particularly in a first-in-class or early-stage product environment, is a significant advantage.

• Strong expertise in rare diseases and/or neurodevelopmental disorders.

• Demonstrated capacity to work independently, entrepreneurially, and collaboratively in a lean organizational structure.

• In-depth knowledge of the Italian healthcare system, reference centers, and national rare disease networks.

• Highly hands-on, adaptable, and comfortable navigating ambiguity.

• Strong cross-functional understanding and collaboration skills.

• Solid scientific credibility with the ability to influence without direct authority.

• Exceptional communication skills in both Italian and English.

• High ethical standards and a robust understanding of medical compliance in Italy and the EU.

🏝️ Benefits

• Competitive base salary, bonus structure, and equity packages for new hires and ongoing employees.

• Comprehensive medical, dental, and vision insurance coverage.

• Employer-sponsored life, disability, business travel, and Employee Assistance Program (EAP) coverage.

• 401(k) Plan featuring a fully vested company match of 1:1 up to 5%.

• Employee Stock Purchase Plan with a two-year price lock-in.

• More than 15 vacation days.

• 13-15 paid holidays, including office closure from December 24th to January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefits.

• Tuition assistance program.