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Senior Director, Real-World Evidence (RWE) - Global Rare Diseases

chiesi usa, inc. United State
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AI Summary

Leads global RWE strategy and governance for Chiesi Global Rare Diseases portfolio, overseeing evidence generation across development, regulatory, and commercial objectives. Manages multidisciplinary teams, external partnerships, and scientific methodologies to deliver actionable insights for rare disease therapies. Requires advanced degree, 12+ years of RWE experience, and proven leadership in multinational observational research programs.

Key Highlights
Develop and own comprehensive RWE vision and strategic roadmap for HIDO portfolio
Lead governance activities including budget oversight and program performance monitoring
Manage and mentor multidisciplinary RWE team and matrix organizations
Establish strategic partnerships with academic institutions and data providers
Oversee scientific integrity and innovative methodologies including AI/ML
Key Responsibilities
Develop and own comprehensive RWE vision and strategic roadmap for HIDO portfolio aligned with corporate objectives
Drive organization-wide adoption of RWE principles and processes through communication and change leadership
Lead governance activities including setting evidence generation priorities, budget oversight, and monitoring program performance
Ensure robust integration of RWE strategies across therapeutic areas and geographical regions
Lead capacity building initiatives to enhance RWE competencies and establish best practices
Design and implement frameworks for continuous improvement in evidence generation
Manage and mentor multidisciplinary team fostering collaborative and inclusive work environment
Identify, establish, and govern strategic partnerships with data providers, academic collaborators, and healthcare organizations
Maintain active presence in scientific communities and contribute to knowledge dissemination
Serve as global expert on RWE methodology ensuring adoption of innovative analytic approaches
Oversee scientific integrity across study protocols, analytic plans, and publication strategies
Guide design and interpretation of observational research to produce reliable insights
Advise senior leadership within Medical Affairs, Clinical Development, Regulatory, Market Access, and Commercial teams
Support due diligence for licensing, acquisition, and business development through evidence assessments
Oversee budget management, resource allocation, and delivery timelines across RWE initiatives
Govern study prioritization and execution to ensure alignment with strategic goals
Lead matrix teams, manage external consultants, and foster talent development within RWE function
Technical Skills Required
Real-world evidence (RWE) Epidemiology Health economics Data analytics Scientific methodology
Benefits & Perks
Comprehensive healthcare programs
Work-life balance initiatives
Robust relocation support
Flexible working arrangements
Tax assistance services for foreign colleagues

Job Description


About Us

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a 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. Discover more here.

Who We Are Looking For

This is what you will do

The Senior Director, RWE is accountable for the global real-world evidence generation vision, strategy, governance, and organizational leadership for the HIDO portfolio within Global Rare Diseases (GRD). This role oversees the development and implementation of integrated evidence generation plans (IEGPs) across all HIDO assets and ensures alignment with development, regulatory, medical, market access, and commercial objectives.

The Senior Director serves as the enterprise RWE leader for the HIDO portfolio, providing strategic oversight of evidence generation activities supporting marketed and pipeline products and future pipeline or acquired assets. The position is responsible for leading the HIDO RWE organization, including management and development of the Director, RWE, and ensuring delivery of a high-impact portfolio of outcomes research, real-world evidence, patient-centered research, and post-launch evidence generation initiatives.

You’ll be responsible for:

  • RWE Strategy & Global Leadership
    • Develop and own a comprehensive RWE vision and strategic roadmap for the HIDO portfolio, aligned with corporate objectives and evolving healthcare landscapes.
    • Drive organization-wide adoption of RWE principles and processes through effective communication, advocacy, and change leadership.
    • Lead governance activities including setting evidence generation priorities, budget oversight, and monitoring program performance.
    • Ensure robust integration of RWE strategies across therapeutic areas and geographical regions to maximize evidence impact.
  • Organizational Capability and Development
    • Lead capacity building initiatives to enhance RWE competencies, establish best practices, and institutionalize standards within HIDO.
    • Design and implement frameworks that foster continuous improvement in evidence generation, ensuring alignment with clinical, regulatory, and commercial needs.
    • Manage and mentor a multidisciplinary team, fostering a collaborative, inclusive, and high-performance work environment.
  • External Partnerships and Scientific Engagement
    • Identify, establish, and govern strategic partnerships with data providers, academic collaborators, consortia, and healthcare organizations to enrich evidence resources.
    • Maintain active presence in scientific communities, contributing to knowledge dissemination and positioning the organization as a leader in RWE.
  • Scientific Methodology and Innovation
    • Serve as the global expert on RWE methodology, ensuring adoption of innovative analytic approaches like AI/ML and advanced epidemiology techniques.
    • Oversee scientific integrity across study protocols, analytic plans, and publication strategies, ensuring methodological consistency and quality.
    • Guide the design and interpretation of observational research to produce reliable, actionable insights.
  • Cross-functional Collaboration and Influence
    • Advise senior leadership within Medical Affairs, Clinical Development, Regulatory, Market Access, and Commercial teams to integrate RWE into strategic decision-making.
    • Support due diligence for licensing, acquisition, and business development through evidence assessments.
  • Operational Leadership and Governance
    • Oversee budget management, resource allocation, and delivery timelines across RWE initiatives.
    • Govern study prioritization and execution to ensure alignment with strategic goals and high-impact results.
    • Lead matrix teams, manage external consultants, and foster talent development within the RWE function.


You will need to have

  • Advanced degree (PhD, DrPH, MD, PharmD, MSc) in epidemiology, public health, health economics, or related field.
  • 12+ years of experience in RWE, HEOR, epidemiology, or observational research in pharma/biotech or related setting.
  • Demonstrated success leading global RWE and evidence generation strategy at a portfolio level, including responsibility for multiple assets across development, launch, and lifecycle management.
  • Proven experience developing and governing Integrated Evidence Generation Plans (IEGPs) and aligning evidence strategies with medical, regulatory, market access, and commercial objectives.
  • Extensive knowledge of real-world data sources and secondary data analytics, including claims, electronic health records, registries, specialty pharmacy data, patient-generated data, and linked datasets.
  • Demonstrated leadership of large-scale, multinational observational research programs, registries, and post-authorization/post-launch evidence generation initiatives.
  • Strong track record of influencing executive leadership and driving cross-functional decision-making through evidence-based insights.
  • Experience supporting regulatory submissions, health technology assessment (HTA), payer interactions, market access strategies, and value demonstration initiatives through RWE.
  • Demonstrated success establishing and managing strategic collaborations with academic institutions, research networks, data partners, patient advocacy organizations, and healthcare systems.
  • Prior people leadership experience, including management and development of direct reports and matrix teams.
  • Experience leading organizational change and building RWE capabilities, processes, and governance frameworks within a global environment.


We would prefer for you to have

  • Rare disease experience strongly preferred; experience in hematology, immunology, dermatology, ophthalmology, or specialty medicines highly desirable.


Location

Hybrid role based in Boston, MA office. Up to 20% domestic and international travel availability required.

Compensation

The annual base pay for this position ranges from $223,000 to $335,000. 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.

What We Offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.


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