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Recordati

Vice President, Medical Affairs Rare Diseases

Hemel Hempstead
Posted 29 days ago
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VP, Medical Affairs, Rare Diseases Business Unit (RRD)

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. S/he will champion patient-centricity as the key driver of business decisions and serve as a spokesperson for Recordati within the scientific community.

This role requires collaborative, fast-paced, and intercultural agility, acting as a role model for Recordati’s values and a champion of ethics and integrity. The candidate will collaborate closely with global cross-functional teams, including clinical development, regulatory, commercial, and business development.


Overall Objectives

  • Provide strategic medical leadership across Rare Diseases, shaping and executing global Medical Affairs strategies in partnership with Commercial and Business Development.
  • Ensure proactive, timely, high-quality medical input across cross-functional teams.
  • Standardise and streamline Medical Affairs processes globally (e.g., systems, KPIs) while fostering best-practice sharing.
  • Ensure effective, compliant communication of scientific information, generating robust evidence to enhance product value, safety, and portfolio growth.
  • Adhere to ethical standards, corporate governance, and international regulatory frameworks in all activities.
  • Lead the development and implementation of patient-centric Medical Affairs strategies that support the BU’s growth and innovation goals.

Key Responsibilities

Medical Affairs Strategy & Execution

  • Develop and implement integrated Medical Affairs strategies and plans for rare disease products.
  • Lead the creation of Integrated Evidence Plans (IEPs), aligning with Clinical Development, Regulatory, Market Access, and Commercial teams.

Medical Leadership & Lifecycle Management

  • Provide medical leadership and expertise to guide Rare Diseases Business Unit (BU) strategy.
  • Deliver medical insights for Business Development assessments and lifecycle management strategies for rare disease assets.
  • Support post-marketing studies addressing unmet medical needs.
  • As part of the BU Leadership Team, guide the generation and publication of robust medical evidence to support product differentiation.

Evidence Generation & Publications

  • Collaborate with the Group Medical Evidence Generation Lead to design and execute global evidence generation plans, including Real-World Evidence (RWE) and Independence Suite Studies (ISS).

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Medical Affairs Community & Talent Development

  • Build and foster a high-performing Medical Affairs community across the BU, promoting continuous learning and talent development.
  • Ensure global and affiliate-level medical personnel are properly trained, equipped, and aligned with consistent operational approaches.

Cross-Functional Collaboration

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

External Engagement & Scientific Partnerships

  • Strengthen relationships with Key Opinion Leaders (KOLs), Scientific Societies, healthcare professionals, and patient advocacy groups in rare disease domains.
  • Lead the development of medical education programs tailored to rare disease stakeholders, including KOLs, HCPs, and patient organisations.
  • Represent Recordati’s medical perspective externally, in partnership with the Patient Partnership team, advancing patient-centred advocacy.

Performance & Budget Management

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

Medical Governance & Compliance

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

Required Skills & Experience

The successful candidate must be an experienced, credible, and influential Medical Affairs executive thriving in a fast-paced, science-driven, and growth-oriented environment. They should possess:

  • Deep medical and scientific expertise in rare diseases and/or specialty pharmaceuticals, paired with strategic acumen to shape global Medical Affairs agendas.
  • Decision-making prowess, forward-thinking leadership, and the ability to inspire teams through scientific rigor, cross-functional collaboration, and patient-centric decision-making.
  • Patient advocacy as a core driver of strategy.

Core Qualifications

  • 20+ years in the pharmaceutical industry, with experience in global or regional Medical Affairs leadership roles; an M.D. degree is mandatory.
  • Board certification in a relevant specialty is preferred.
  • Proven ability to define and execute medical strategies that advance product value, differentiation, and lifecycle management in rare diseases.
  • Strong scientific and analytical skills, translation of complex data into impactful medical insights and strategic recommendations.
  • Establish credibility in engaging with:
    • Key Opinion Leaders (KOLs)
    • Scientific societies
    • Regulatory bodies
    • External stakeholders
  • Deep understanding of global medical governance, compliance, pharmacovigilance, and regulatory frameworks affecting Medical Affairs.
  • Experience building high-performing teams, mentoring medical talent, fostering a culture of scientific excellence and ethical business practices.
  • Operating effectively in multicultural, matrixed environments, influencing without formal authority while driving cross-functional alignment.
  • Excellent communication skills, including the ability to simplify complex scientific concepts for diverse internal and external audiences.
  • Demonstrated integrity, sound judgment, and commitment to patient-centred decision-making.

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Required Behaviours & Competencies

  • Collaboration: Builds trust and Effective cross-functional collaboration between Medical Affairs, Integrated Operations, Commercial, Market Access, Regulatory, Patient Safety, and local/regional teams.
  • Psychological Safety & Trust: Actively listens, invites feedback, and values diverse perspectives.
  • Knowledge Sharing: Proactively disseminates medical insights for timely, informed decision-making.
  • Strategic Contribution: Identifies improvement opportunities for the global Medical Affairs function to align with RRD priorities.
  • Risk-Aware Innovation: Challenges current practices, driving improvements while managing risks responsibly.
  • Patient-First Approach: Prioritises patient needs, scientific credibility, and RRD business priorities, ensuring focused and lean execution.
  • Compliance & Quality: Produces clear, structured, compliant, and actionable work, holding self and others to high ethical and operational standards.

Required Languages

  • Fluency in English is mandatory.
  • Knowledge of additional languages is a strong advantage.

Travel Requirement

  • 20-30% worldwide travel expected.
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Skills

Medical Affairs Strategy
Rare Disease Expertise
Lifecycle Management
Evidence Generation
KOL Engagement
Cross-functional Leadership
Budget Management
Regulatory Compliance
Patient Centricity
Clinical Development
Pharmacovigilance
Medical Governance
Strategic Planning
Talent Development
Scientific Communication
Market Access

Location

Milan, Lombardy, Italy

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