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Director, Medical Affairs Europe
About The Position
Position Summary:
The European Regional Medical Director acts as a senior medical leader responsible for developing and implementing the Medical Affairs strategy across a designated European region. This role bridges the gap between global strategy and local execution, ensuring high-quality evidence generation, scientific exchange with Key Opinion Leaders (KOLs), and regulatory compliance (e.g., MDR, EMA guidelines). The successful candidate will lead cross-functional initiatives to support product launches and lifecycle management, providing clinical and scientific expertise to internal stakeholders.
Key Responsibilities:
Strategy Development: Contribute to the creation of Global Medical plans aligned with business and regulatory objectives and lead the creation and execution of the regional medical affairs strategy, ensuring alignment with global objectives and local market needs.
Scientific Engagement: Act as the senior clinical subject matter expert developing, maintaining, and leveraging relationships with top European KOLs, patient advocacy groups, and scientific societies to foster partnerships and gather insights.
Represent the company at scientific and medical forums, enhancing visibility and credibility within the scientific community.
Collaborate with internal executive leadership to align clinical evidence with market access, clinical affairs, and regulatory affairs priorities.
Evidence Generation: Provide guidance on clinical trial design taking into account Scientific societies guidelines and market access needs and oversee the execution of regional real-world evidence (RWE) studies, post-marketing surveillance, and investigator-initiated studies (IIS).
Regulatory & Compliance: Ensure all medical activities comply with European regulatory requirements (EMA), industry codes (e.g., EFPIA, ABPI), and internal policies. Act as a medical reviewer/final signatory for promotional and scientific materials.
Launch Readiness: In alignment with other regions, build a global and implement regional scientific communication strategies for new product launches, including publication planning, medical education programs, and MSL training.
Cross-functional Leadership: Act as a strategic partner to Market Access, Regulatory, and Commercial teams to maximize medical input during strategy planning and HTA submissions.
Team Leadership: Provide strategic direction, mentoring, and, where appropriate, direct line management to regional medical staff/MSLs. Drive talent development, succession planning, and culture of excellence.
Budget Management: Manage regional medical budgets, ensuring optimal resource allocation for medical projects
Requirements
Education: Advanced scientific degree (MD, PharmD, or PhD) required.
Experience: Minimum of 7–10+ years of experience in Medical Affairs within the pharmaceutical or medical device industry, specifically within Europe.
Leadership: Demonstrated experience in leading regional teams, managing cross-functional projects, and working in a matrix environment.
Technical Knowledge: Deep understanding of the European regulatory landscape, including EU MDR/IVDR for devices or EMA requirements for pharmaceuticals.
Scientific Acumen: Strong background in the CNS area, and preferably in the movement disorders space with ability to interpret and communicate complex data.
Network: Existing network of KOLs across major European countries.
Key Competencies
Communication: Exceptional English verbal and written communication skills; proficiency in other major European languages is an asset.
Strategic Thinking: Ability to translate high-level strategies into actionable, compliant, regional plans.
Influence: Strong stakeholder management and negotiation skills.
Flexibility: Ability to thrive in a fast-paced, changing environment.
Travel Requirements: Flexibility to travel across Europe (approximately 30-50%) for congresses, field visits with MSLs, and KOL engagements.