Vice President, Real World Evidence

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, including enhancing healthcare professional (HCP) confidence in therapy adoption, improving patient acceptance and adherence through evidence of real-world effectiveness, and addressing unmet needs in diverse populations.

Given the significant challenges in recruiting for classic randomized clinical trials in rare diseases and the heightened demand for RWE, the VP of RWE, strategically positioned within the Global Rare Disease Division, will lead the enterprise-wide RWE strategy across the Chiesi group to address this critical need.

Based in Boston with hybrid flexibility, you will collaborate with R&D, market access, and digital technology teams, utilizing large datasets such as claims data, electronic health records (EHRs), and registries, and leveraging advanced analytics like natural language processing (NLP) to unlock actionable insights. As a global role, the candidate must be well-versed in navigating diverse geographies, datasets, and regulatory environments, ensuring RWE strategies are tailored to regional healthcare systems and data ecosystems. The Global VP of RWE will oversee worldwide responsibilities, leading initiatives that span multiple continents and regulatory landscapes, directly informing global healthcare policies and patient access to innovative therapies in rare diseases.

This position requires navigating the complexity of managing multiple stakeholders without direct org chart authority, spanning across R&D, commercial, HEOR, and business units focused on rare diseases, while integrating with the AIR and CARE franchises to align on cross-portfolio needs and priorities across multiple geographies.
Starting with a few direct reports, the candidate will have the opportunity to grow and expand the RWE team strategically, scaling operations to meet the evolving demands of our ambitious pipeline and international partnerships. This high-impact VP-level role will position the candidate at the forefront of biotech innovation, empowering you to drive transformative changes that accelerate drug development and market entry on a global scale, making it an ideal platform for visionary leaders to leave a long-lasting legacy in the industry.

The VP will report directly to the Global Medical SVP of Rare Diseases and serve on the Global Rare Diseases Leadership Team, driving enterprise-wide RWE strategy. The VP will be involved in global RWE governance committees, shape C-suite decisions on data investments, and set the strategic vision for RWE integration across all therapeutic areas and geographies. This is a unique opportunity to create a transformative RWE program within a forward-thinking organization.

• 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 least 5 years in a leadership role.
• Proven track record of building and scaling RWE programs, ideally in a biotech or pharmaceutical setting.
• Deep understanding of Phase 3, 3b, and 4 trial design, regulatory requirements, and market access strategies.
• Expertise in digital health technologies and advanced analytics, including NLP, machine learning, or AI-driven data analysis.
• Entrepreneurial mindset with a passion for innovation and the ability to thrive in a dynamic, fast-paced environment.
• Exceptional leadership and communication skills, with experience managing cross-functional teams and external partnerships.
• Familiarity with RWD sources (e.g., EHRs, claims data, registries) and analytical tools (e.g., Python, R, SQL).

• Experience working with regulatory agencies (e.g., FDA, EMA) on RWE submissions.
• Knowledge of health policy, payer dynamics, and HTA processes.
• Comfort with ambiguity and a proactive approach to building processes from the ground up.
• Strong network within the biotech/pharma industry and RWE community.

This is a hybrid position based in our Boston, MA office.

The annual base pay for this position ranges from $311,850 to $381,150. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.