Director, Real World Evidence, Global Rare Diseases - HIDO

Chiesi Group•Boston, MA

1d•$181,000 - $271,000•Hybrid

About The Position

The Director, RWE is responsible for leading and executing the global RWE strategy and vision for the Hematology, Immunology, Dermatology and Ophthalmology (HIDO) Portfolio within GRD, ensuring the strategy, creation and updating of the integrated evidence generation plan (IEGP), in alignment with cross-functional partners to meet research and commercial objectives. This role drives enterprise-level RWE impact, including building strategic data partnerships, advancing innovative methodologies, and influencing cross-functional decision-making. You’ll be responsible for: RWE Strategy & Leadership Act as a change agent, effectively communicating the value of RWE and influencing adoption of new processes and approaches. This includes: Lead the global RWE strategy for the HIDO GRD portfolio, acting as the strategic RWE leader across development, regulatory, and commercialization phases, and ensuring its integration into regulatory, payer, and clinical decision-making across the HIDO Portfolio including Iron overload (e.g., beta‑thalassemia, SCD) Therapeutic Area (TA), Epidermolysis bullosa TA, Leber’s Hereditary Optic Neuropathy TA, and future pipeline or acquired assets. Increase the integration of RWD sources to enhance evidence-based decision making through research programs, while providing medical leadership as appropriate on cross-functional teams supporting local and global needs in a prioritized manner. Publish, where appropriate in high impact journals. Capability Building & Organizational Leadership Continuously improve RWE capabilities, processes, and infrastructure to support global and local evidence generation for HIDO Build and scale RWE capabilities as a competitive advantage for GRD Establish best practices, standards, and ways of working across regions Lead change management to embed RWE into core organizational processes External Data & Partnership Strategy Lead identification, evaluation, and execution of external RWD partnerships and data acquisition strategies Oversee due diligence, contracting support, and governance of external data sources and collaborations Build long-term strategic relationships with academic institutions, data vendors, consortia, and healthcare systems Scientific & Technical Leadership Foster the appropriate use and adoption of appropriate analytic technologies to improve RWE reliability and applicability to provide insights that matter to internal and external stakeholders Provide senior scientific leadership and deep technical expertise in observational research, epidemiology, and RWE methodologies Guide study design, analytics strategy, and interpretation of evidence Ensure adoption of innovative approaches, including AI/ML and advanced analytics, in RWE generation Cross-Functional Influence & Integration Act as the RWE subject matter expert within cross-functional teams (Medical, Clinical Development, Market Access, Regulatory) Influence asset strategies, development plans, and access strategies Lead alignment of RWE priorities across global and regional stakeholders Evidence Generation Oversight Provide executive oversight of RWE studies, registries, and non-interventional programs, ensure studies are aligned to strategic priorities and deliver high-impact outcomes Maintain governance of study concept development and prioritization External Scientific Leadership & Visibility Represent Chiesi externally in scientific forums, consortia, and partnerships Drive publication strategy and dissemination of RWE insights Maintain awareness of emerging trends, regulatory guidance, and methodological advances Leadership & Matrix Management Lead cross-functional and multidisciplinary teams in a matrix environment Oversee budgets, timelines, and resource allocation across RWE initiatives Manage consultants, mentor junior team members and as needed, direct reports over time

Requirements

Advanced degree (PhD, DrPH, MD, PharmD, MSc) in epidemiology, public health, health economics, or related field
8+ years of experience in RWE, HEOR, epidemiology, or observational research in pharma/biotech or related setting
Demonstrated success in leading RWE strategy at asset or portfolio level
Strong experience in real-world data sources (claims, EHR, registries, etc.)
Proven track record of building partnerships and influencing senior stakeholders
Experience supporting regulatory and/or market access use of RWE
Deep expertise in epidemiology and RWE methodologies
Ability to translate evidence into business and clinical impact
Demonstrated ability to influence senior stakeholders and cross-functional leadership
Strong executive communication skills
Experience with advanced analytics, AI/ML, and innovative RWE approaches
Ability to shape data strategy and infrastructure decisions
Strong governance and oversight of complex, multi-country studies and programs
Ability to manage competing priorities and large-scale initiatives

Nice To Haves

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

Responsibilities

Lead the global RWE strategy for the HIDO GRD portfolio, acting as the strategic RWE leader across development, regulatory, and commercialization phases, and ensuring its integration into regulatory, payer, and clinical decision-making across the HIDO Portfolio including Iron overload (e.g., beta‑thalassemia, SCD) Therapeutic Area (TA), Epidermolysis bullosa TA, Leber’s Hereditary Optic Neuropathy TA, and future pipeline or acquired assets.
Increase the integration of RWD sources to enhance evidence-based decision making through research programs, while providing medical leadership as appropriate on cross-functional teams supporting local and global needs in a prioritized manner.
Publish, where appropriate in high impact journals.
Continuously improve RWE capabilities, processes, and infrastructure to support global and local evidence generation for HIDO Build and scale RWE capabilities as a competitive advantage for GRD
Establish best practices, standards, and ways of working across regions
Lead change management to embed RWE into core organizational processes
Lead identification, evaluation, and execution of external RWD partnerships and data acquisition strategies
Oversee due diligence, contracting support, and governance of external data sources and collaborations
Build long-term strategic relationships with academic institutions, data vendors, consortia, and healthcare systems
Foster the appropriate use and adoption of appropriate analytic technologies to improve RWE reliability and applicability to provide insights that matter to internal and external stakeholders
Provide senior scientific leadership and deep technical expertise in observational research, epidemiology, and RWE methodologies
Guide study design, analytics strategy, and interpretation of evidence
Ensure adoption of innovative approaches, including AI/ML and advanced analytics, in RWE generation
Act as the RWE subject matter expert within cross-functional teams (Medical, Clinical Development, Market Access, Regulatory)
Influence asset strategies, development plans, and access strategies
Lead alignment of RWE priorities across global and regional stakeholders
Provide executive oversight of RWE studies, registries, and non-interventional programs, ensure studies are aligned to strategic priorities and deliver high-impact outcomes
Maintain governance of study concept development and prioritization
Represent Chiesi externally in scientific forums, consortia, and partnerships
Drive publication strategy and dissemination of RWE insights
Maintain awareness of emerging trends, regulatory guidance, and methodological advances
Lead cross-functional and multidisciplinary teams in a matrix environment
Oversee budgets, timelines, and resource allocation across RWE initiatives
Manage consultants, mentor junior team members and as needed, direct reports over time