Vice President, IT​/Tech

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a business unit established in February 2020 focused on research, development and commercialization of treatments and patient support services for rare and ultra‑rare disorders. The unit is based in Boston, Massachusetts, with strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.

The Global Medical VP of Real-World Evidence will be a visionary leader responsible for building and scaling our RWE function, shaping the strategy from the ground up. This role combines scientific rigor, digital innovation, and entrepreneurial drive to harness real-world data (RWD) for regulatory submissions, market access, and optimized patient outcomes.

• Strategy and Leadership:
  • Develop and execute a comprehensive RWE strategy aligned with the company’s mission to advance Phase 3 trials and post-approval studies.
  • Build the RWE function from its early stages, establishing processes, infrastructure, and a high‑performing team.
  • Act as a thought leader, fostering an entrepreneurial culture that drives innovation and collaboration across departments.
  • Set the global strategic direction for RWE, ensuring alignment with corporate objectives and influencing board‑level investment decisions.
• Integration with R&D:
  • Partner closely with R&D to integrate RWE into Phase 3 trial design, ensuring robust evidence generation for regulatory submissions through external control arms, patient stratification, and endpoint validation.
  • Identify opportunities to use RWD to optimize trial protocols, patient recruitment, and endpoint selection.
  • Support post‑market surveillance and label expansion through RWE studies.
• Market Access and Stakeholder Engagement:
  • Collaborate with market access teams to generate RWE that demonstrates the clinical value, safety, and effectiveness of therapies to payers, providers, and regulators.
  • Engage with external stakeholders (e.g., regulatory agencies, healthcare providers, patient advocacy groups) to align RWE outputs with industry needs, enhancing HCP trust and patient acceptance.
  • Provide medical evidence to support health technology assessments (HTAs) and reimbursement strategies.
  • Drive global stakeholder alignment, harmonizing diverse regional requirements to ensure RWE supports universal patients’ access to medicines, HCPs’ acceptance and data‑enabled shared decision‑making.
• Digital Innovation and NLP Integration:
  • Leverage digital technologies and advanced analytics, including NLP, to extract insights from unstructured data sources (e.g., EHRs, social media, patient forums).
  • Drive the adoption of cutting‑edge tools and platforms to enhance data processing, analysis, and visualization.
  • Partner with digital technology experts to ensure scalable, secure, and compliant data infrastructure for RWE generation.
• Team Building and Cross‑Functional
  
  Collaboration:
  • Recruit, mentor, and lead a diverse team of data scientists, epidemiologists, and analysts to execute RWE initiatives.
  • Foster collaboration with cross‑functional teams, including clinical development, regulatory affairs, and commercial teams, to ensure seamless integration of RWE insights.
  • Champion a culture of innovation, encouraging creative problem‑solving and agile execution.
  • Orchestrate cross‑franchise collaboration, ensuring RWE strategies integrate seamlessly with the AIR and CARE franchises to address portfolio‑wide objectives.
• Regulatory and Compliance:
  • Ensure RWE studies meet regulatory standards (e.g., FDA, EMA guidelines) for use in submissions and decision‑making across global markets.
  • Maintain compliance with data privacy regulations (e.g., HIPAA, GDPR) and ethical standards in RWD utilization.

• Advanced degree (PhD, MD, or equivalent) in epidemiology, health economics, data science, or a related field.
• 10+ years of experience in RWE, health outcomes research, or related fields, with at…