Medical Affairs Director EU & ROW

Medical Affairs Director EU & ROW

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

Reporting to the Global Head of Medical Affairs, the Medical Affairs Director EU & ROW is part of the CMO (Chief Medical Officer) organization and works closely with Clinical Development, Pharmacovigilance, Regulatory Affairs, Market Access, Marketing, and Country Medical Directors.

The position supports the development and delivery of a robust medical strategy, including scientific exchange, data generation, publications, insights, and thought leader engagement, ensuring all activities uphold the highest standards of compliance and ethics. As a key member of the global medical team, the role fosters a collaborative, knowledge- sharing culture across regions and functions.

Key Responsibilities

• Support the Head of Medical Affairs in developing and executing the global medical affairs strategy for current and future pipeline indications.
• Focus strategy and activities on the key medical affairs pillars: (i) Scientific Exchange (ii) Data Generation (iii) Insights Generation (iv) Customer Advocacy and Relations (v) Medical Education (vi) Compliance with relevant standards (ICH-GCP, SOPs, etc.).
• Guide and implement the integrated data generation plan, including publications, phase IV protocols, and Investigator Sponsored Trials; oversee medical assessment and approvals.
• Represent the company as a key clinical expert with medical and patient associations, and collaborate with commercial, market access, and affiliate medical teams to align global and local strategies.
• Lead and implement medical education events, training programs, and manage medical/scientific content for internal and external stakeholders.
• Oversee medical governance and compliance, including MLR process support, material review and approval in VEEVA, issue management, and medical standard response letter for Vamorolone in DMD.
• Provide medical expertise for product evaluations, benefit assessments, and support local launch needs; manage budget and resource allocation in consultation with the Head of Medical Affairs.
• Develop and manage Key Opinion Leader networks, ensure medical representation in external organizations, and act as a professional, compliant, and goal-driven collaborator.

Required Qualifications & Experience

• Accredited physician or registered pharmacist with a specialty degree or several years’ experience in neuromuscular diseases; or Life Science graduate with a higher degree (MSc, MBA, PhD, or similar);
• Minimum 8 years of medical affairs experience in the pharmaceutical industry, ideally within the therapeutic area;
• 3+ years of line management and leadership experience;
• Proven track record in producing research publications (posters, presentations, and papers) and in supporting HTA processes;
• Prior experience as medical reviewer/approver in VEEVA;
• Experience in design, planning, and conduct of clinical research protocols is a plus;
• Knowledge and experience in Drug Safety, Regulatory, Health Economics, and/or statistical methods are a plus;
• Fluent English (spoken and written); strong ability and mandate to shape the external environment and partner effectively with internal stakeholders, especially Market Access and Marketing.

Required Competencies & Skills

• Expert knowledge of the ABPI Code of Practice; recognised Thought Leader in compliance;
• Advanced understanding of ICH GCP;
• Strong people leader with proven team development skills;
• Advanced user of VEEVA and related systems;
• Skilled in publication and project management;
• Experienced in Thought Leader engagement and relationship management;
• Financially savvy, with solid budget management skills;
• Strong commercial mindset and strategic acumen.

For this position, the relevant working/residency permit or Swiss/EU-citizenship is required.