Danilo De Spirito

Pharma Business Leader ⫸ Sales & Business Development | Market Access, Public Affairs, Tender & Regulatory | People Development

Italy

About

Visionary leader with a proven track record in Market Access, Regulatory Affairs and Tender Management, and Sales & Marketing driving business expansion and market penetration. Expert in negotiation, pricing strategies, and stakeholder engagement, ensuring accelerated drug reimbursement and seamless market entry. Passionate about orchestrating high-impact commercial strategies, bridging Sales, Marketing, and Market Analysis to optimize product positioning and business development. Adept at building strong relationships with key regulatory bodies, healthcare institutions, and policymakers, shaping the industry landscape. 🔥 Key Strengths: ✔ Leadership & Cross-Functional Team Management ✔ High-Level Negotiations & Strategic Pricing ✔ Market Access Acceleration & P&L Management ✔ Business Development & Commercial Excellence

Experience

  • Business Unit Director at Sobi - Swedish Orphan Biovitrum AB (publ)
    Dec 2025 - Present · 8 mos

    Business Unit Director – Complement-mediated Diseases (CMD). Leading the creation of a new business unit in Complement-Mediated Diseases, ensuring continuity in hematology while building the nephrology area. Member of the leadership team, contributing to portfolio evolution through innovation, cross-functional alignment and sustainable impact in specialty care.

  • Bayer (14 yrs 8 mos)
    • Head of Amyloidosis - Cardiovascular
      Jun 2025 - Dec 2025 · 7 mos

      Responsible for launching a new, strategic business unit focused on amyloidosis within the cardiovascular area with high impact on Bayer pharma business revenue. Part of the Pharma Leadership Team, with a mandate to drive innovation, cross-functional collaboration, and long-term growth in a high-impact therapeutic field.

    • Market Innovation Access, Regulatory & Tender Head
      Jun 2024 - Jun 2025 · 1 yr 1 mo

    • Market & Innovation Access Head
      Aug 2023 - Jun 2025 · 1 yr 11 mos

      Country access head for Bayer pharma therapies.Member of the Italian Pharma Leadership Team.

  • Clinical Trial Monitor at Hoffmann-La Roche
    Jun 2008 - May 2011 · 3 yrs

    • The contact point with trial centers during clinical studies and approval process of the drugs Rituximab and Tocilizumab • Identified main centers and supported clinical operations while collecting patient's documentation and related study results • Performed audits to ensure compliance with Good Clinical Practice ► Up to 2009 worked as a Country Clinical Trial Assistant involved in regulatory approval within the oncology field

  • Field Product Specialist at Eli Lilly
    Sep 2007 - Jun 2008 · 10 mos

    • Dealt with business development strategies and executed commercial/marketing policies • Promoted the pharmaceutical product portfolio to hospitals in the southern Milan area • Launched new products such as Byetta