Vice President, Medical Affairs Rare Diseases

Job Purpose

The VP, Medical Affairs, Rare Diseases BU will provide strategic medical leadership and oversight to support the continued growth of the Rare Diseases (RRD) portfolio. The role will champion patient‑centricity as a key driver of business decisions and act as a spokesperson for Recordati within the scientific community, collaborating closely with cross‑functional colleagues globally—clinical development, regulatory, commercial, and business development.

Overall Objectives

• Provide strategic medical leadership and oversight across Rare Diseases to shape and execute global medical affairs strategies, working closely with commercial and business development colleagues.
• Ensure proactive, timely and highly qualified medical input is provided within cross‑functional teams.
• Ensure RRD Medical Affairs Teams adopt consistent and efficient processes across geographies (e.g., in terms of systems, tools, KPIs) and foster best‑practice sharing.
• Ensure the effective and compliant communication of scientific and medical information while generating robust evidence to enhance product value and safety, ultimately contributing to the Rare Diseases portfolio growth.
• Ensure all medical activities adhere to ethical standards, corporate governance and international regulatory frameworks.
• Provide strategic medical leadership across the Rare Diseases BU, ensuring robust, patient‑centric medical affairs strategies that support the BU’s growth and innovation goals.

Key Responsibilities

Medical Affairs Strategy and Execution

• Develop and implement integrated Medical Affairs strategies and plans for rare diseases products.
• Lead the creation of Integrated Evidence Plans (IEPs) and ensure alignment with clinical development, regulatory, market access and commercial.

Medical Leadership & Lifecycle Management

• Provide medical leadership and expertise to guide medical activities across the Business Unit.
• Provide medical input into BD assessments and lifecycle management strategies for rare disease assets.
• Support post‑marketing studies aligned with unmet medical needs.
• As a member of the BU Leadership Team, provide expert guidance and facilitate the generation and publication of robust medical evidence to support the value of our brands.

Evidence Generation and Publications

• Collaborate with the Group Medical Evidence Generation Lead to design and execute global evidence generation plans, including RWE and ISS.

Medical Affairs Community and Talent Development

• Build and nurture a high‑performing Medical Affairs community across the BU, fostering continuous learning and talent development.
• Ensure medical personnel at both global and affiliate levels are properly trained, equipped, and aligned with consistent, efficient operational approaches.

Cross‑functional Collaboration

• Support early development and launch readiness for new indications and assets.
• Ensure proactive and qualified medical input to Clinical Development, Regulatory Affairs, Market Access, Pharmacovigilance and Commercial teams.

External Engagement and Scientific Societies Partnership

• Work with affiliates to build and maintain strong relationships with KOLs, scientific societies, healthcare professionals and patient advocacy groups in rare disease domains.
• Lead the development of medical education programmes tailored to rare disease stakeholders, including KOLs, HCPs and patient organisations.
• Represent the company’s medical perspective externally in partnership with the Patient Partnership team, strengthening scientific dialogue and advancing patient‑centred advocacy.

Performance and Budget Management

• Define and monitor KPIs for Medical Affairs initiatives, ensuring tools and systems are in place to measure success.
• Manage the Medical Affairs budget, ensuring efficient resource allocation.

Medical Governance and Compliance

• Ensure compliance with SOPs, ethical standards and regulatory requirements across all medical activities.
• Collaborate with QA and Regulatory Affairs to maintain governance frameworks for rare disease products, including medicinal products, devices and compassionate use programmes.

Required Skills and Experience

• 20+ years in the pharmaceutical industry, including experience in global or regional Medical Affairs leadership roles.
• M.D. degree required; board certification in a relevant specialty preferred.
• Proven ability to define and execute medical strategies that advance product value, differentiation and