Medical Affairs Director, Italy

Santhera Pharmaceuticals; Venezia; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

A Swiss specialty pharmaceutical company is seeking a Medical Affairs Director in Italy. This role involves leading medical affairs strategies for rare diseases, managing a medical team, and ensuring regulatory compliance. Ideal candidates will have a strong background in medical affairs, excellent relationship-building skills, and a doctorate in a relevant scientific field. The position requires fluency in Italian and offers a dynamic work environment.

Competenze

• Minimum of 10 years of experience in medical affairs with focus on product launches.
• Experience in rare diseases and clinical work preferred.
• Knowledge of regulatory and compliance requirements in Italy.

Mansioni

• Provide strategic and scientific leadership within medical affairs.
• Develop and implement Italy Medical Affairs plans.
• Recruit and manage high-performing medical affairs team.

Conoscenze

Strategic leadership

Medical communications

Team management

Relationship building

Regulatory compliance knowledge

Project management

Formazione

Bachelor’s degree in a scientific field

Licensed Doctor (MD) or equivalent advanced degree

Descrizione del lavoro

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 :

• Provide effective strategic, scientific and medical leadership
• Line management of medical team (when in place)
• Develop and lead implementation of effective and aligned Italy Medical Affairs plans
• Engage with scientific leaders in relevant therapy areas to raise awareness, provide relevant information and foster scientific exchanges
• Demonstrate effective collaboration and share 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 the company goals

Align the Italy Medical Affairs and publication plans to 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 plan

Support local patient advocacy group engagement plan as aligned with Patient Advocacy Group Programme Manager and HQ

Effectively support market access projects with regards to local value and reimbursement dossiers and relevant medical practices

Contribute to and support, as needed, 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 optimise 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 to 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 holder of an equivalent advanced scientific degree

Minimum of 10 years’ proven experience in medical affairs, with a strong focus on product launches and life cycle management, and in-depth knowledge of regulatory and compliance requirements in Italy

Experience in rare diseases, R&D, and / or clinical work within a hospital or patient association preferred

Experience in the neuromuscular disease landscape 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 organisational skills

Strong strategic vision with a business focus;

able 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, with the ability to navigate ambiguity, take appropriate risks, and make sound decisions in an entrepreneurial business 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.