Sr. Director, Real World Evidence, Global Rare Diseases

Chiesi USA•Framingham, MA

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.