ppSelect how often (in days) to receive an alert: /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: /p pRemote, IT /p pbAbout us /b /p pChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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. /p pAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity and inclusion 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. /p pbChiesi Global Rare Diseases /b /p pChiesi 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. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare 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 . /p pbWhat we are looking for /b /p h3bThis is what you will do /b /h3 pThe Head of Clinical Data Innovation is responsible for defining and executing the clinical data innovation strategy across the Global Rare Disease portfolio. The role drives the adoption of emerging technologies, artificial intelligence, automation, advanced analytics, and modern data management methodologies to accelerate clinical development, improve data quality, increase operational efficiency, and enhance regulatory readiness. /p pThe individual serves as a strategic bridge between Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Digital/IT, and external partners to modernize clinical data processes and establish a future‑ready clinical data ecosystem. /p h3bYou will be responsible for /b /h3 pbStrategic Leadership /b /p ulliDefine and maintain the Clinical Data Innovation roadmap aligned with organizational objectives. /liliIdentify opportunities to leverage AI, machine learning, automation, and digital technologies across the clinical development lifecycle. /liliEstablish long‑term strategies for clinical data architecture, interoperability, standardization, and data reuse. /liliServe as innovation ambassador within Clinical Development and across RD.



/li /ul pbAI and Automation /b /p ulliLead evaluation, implementation, and governance of AI‑enabled solutions supporting: Data review Data cleaning, Query generation, Medical coding, Risk‑based quality management, Database build automation, (Automated) Metadata generation, regulatory submission preparation /liliDevelop frameworks and standard operating procedures for responsible and compliant AI use in accordance with company governance and regulatory expectations. /liliMonitor emerging technologies and assess applicability to clinical development. /li /ul pbData Management Transformation /b /p ulliDrive modernization of clinical data management processes and operating models. /liliLead initiatives to improve scalability and efficiency across internal and outsourced studies. /liliOptimize interactions between Data Management, Programming, Biostatistics, Medical Writing, and Clinical Operations. /li /ul pbTechnology and Platform Leadership /b /p ulliAct as business owner and subject matter expert for clinical data technologies. Collaborate with IT and Digital functions regarding EDC platforms, Data lake architectures, Analytics environments, AI platforms and Data visualization tools /liliLead vendor evaluations and technology selection processes. /liliEstablish KPIs demonstrating technology value and business impact. /li /ul pbAdvanced Analytics and Insights /b /p ulliPromote use of advanced analytics and visualization to improve study oversight. /li liEnable near real‑time monitoring of data quality, study conduct, operational performance and Risk indicators /li liPartner with Biostatistics and Programming to enhance integrated data review capabilities. /li liBuild and manage a portfolio of innovation initiatives. /li liPrioritize projects according to strategic value, feasibility, risk, and return on investment. /li liEstablish business cases and success metrics for innovation projects. /li liPresent innovation strategies and outcomes to senior leadership. /li /ul pbCross‑Functional Collaboration /b /p ulliPartner closely with stakeholders within RD and related to RD (i.e. Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Quality Assurance, IT) /li liBuild relationships with external vendors, technology providers, and industry consortia. /li /ul pbTeam and Capability Development /b /p ulliDevelop organizational capabilities in AI, automation, and innovative data practices. /li liMentor teams on emerging technologies and new ways of working. /li liFoster a culture of experimentation, continuous improvement, and innovation. /li liContribute to workforce planning and future capability models. /li /ul h3bYou will need to have /b /h3 pMaster’s degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Computer Science or related field.



/p p10+ years of experience in the pharmaceutical, biotech or CRO industry, with strong exposure to clinical development. /p pSolid experience in Clinical Data Management and the clinical trial data lifecycle. /p pProven experience in AI, automation, advanced analytics and/or digital innovation applied to clinical development. /p pExperience with clinical data technologies, data architecture, interoperability and data standards. /p pStrong cross‑functional leadership experience across Clinical Development, Data Management, Biostatistics, Clinical Operations and IT/Digital. /p pProven track record of leading clinical data innovation and transformation initiatives, including vendor and technology management. /p h3bLocation /b /h3 pEurope with hybrid or remote options. /p h3bCompensation range /b /h3 phe minimum salary for this role is €59.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /p pThe package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. /p pbWhat we offer /b /p pNo 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. /p pWe 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. /p pChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /p h3DISCOVER ALL OUR JOB OPPORTUNITIES /h3 h3Screen readers cannot read the following searchable map. /h3 pTo activate drag with keyboard, press Alt + Enter. Once in keyboard drag state, use the arrow keys to move the marker. To complete the drag, press the Enter key. To cancel, press Escape. 1 Job /p /p #J-18808-Ljbffr

📌 Head of Clinical Data Innovation (Italia)
🏢 Chiesi Farmaceutici
📍 Italia