Medical Affairs Director, Italy

Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.

Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:

Medical Affairs Director, Italy

Scope of Work

The Medical Affairs Director, Italy reports directly to the General Manager of Italy, with a dotted line to the Head of Medical Affairs EU & ROW. This role is part of the Italian management team and collaborates closely with all other functions based in Italy, as well as affiliated functions such as Clinical Development, Medical Affairs, Marketing, Commercial, Market Access, and others. The overall scope of the role includes:

• Providing effective strategic, scientific, and medical leadership
• Line management of the medical team (when in place)
• Developing and leading implementation of effective and aligned Italy Medical Affairs plans
• Engaging with scientific leaders in relevant therapy areas to raise awareness, provide relevant information, and foster scientific exchanges
• Demonstrating effective collaboration and sharing best practices between Italy, other countries, and HQ

Key Responsibilities

• Recruit, develop, and maintain a high-performing medical affairs team (as needed)
• Identify strategic medical activities to support company goals
• Align Italy Medical Affairs and publication plans with global plans
• Plan and deliver effective and aligned medical communications, congress, and educational plans
• Deliver tactics on budget and on time
• Develop, oversee, and implement Italy scientific/clinical leaders and KOL development plans
• Support local patient advocacy group engagement plans as aligned with Patient Advocacy Group Programme Manager and HQ
• Support market access projects related to local value and reimbursement dossiers and relevant medical practices
• Contribute to and support HQ-led Medical Affairs projects such as product/therapy training platforms, local events, congresses, etc.
• Ensure adherence to Santhera SOPs and Italy country compliance codes of practice, developing local SOPs as necessary
• Act as Italian compliance champion, applying knowledge of country codes to optimize Italy activities
• Ensure effective support and collaboration between Santhera medical affairs team and commercial colleagues
• Collaborate and contribute to high-priority EU/global projects
• Comply with all relevant SOPs
• Deliver timely and compliant review and approval of marketing and medical materials
• Act as the senior medical representative of the company at global projects

Required Qualifications & Experience

• Bachelor’s degree in a scientific field; licensed Doctor (MD), Pharmacist (PharmD), or equivalent advanced scientific degree
• Minimum of 10 years’ proven experience in medical affairs, with a focus on product launches and lifecycle management, and in-depth knowledge of regulatory and compliance requirements in Italy
• Experience in rare diseases, R&D, and/or clinical work within hospitals or patient associations preferred
• Experience in neuromuscular diseases or related therapeutic areas preferred, with familiarity with relevant clinical trial methodologies
• Prior experience in leading and managing teams, including line management responsibilities
• Willingness to travel up to 50% as required

Required Competencies & Skills

• Ability to build and maintain strong relationships with key opinion leaders, healthcare professionals, and internal stakeholders
• Excellent planning and organizational skills
• Strong strategic vision with a business focus; ability to shift between detailed analytical work and strategic thinking
• Proactive and results-oriented, with a demonstrated ability to drive initiatives to successful completion
• Native Italian speaker with outstanding written and verbal communication and presentation skills
• Proven ability to work independently and collaboratively in a dynamic, fast-paced matrix environment
• Resilient and perseverant, able to navigate ambiguity, take appropriate risks, and make sound decisions in an entrepreneurial environment
• Adaptable and open-minded with a solutions-oriented and creative mindset

If you are interested in a multicultural, challenging, and innovative working environment and your profile matches our requirements, we look forward to receiving your online application in English via LinkedIn or email at.

Note for agencies:

Recruitment agencies are kindly requested to refrain from sending unsolicited CVs to Santhera.