Clinical Data Innovation Manager

Job description

About us Chiesi 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. 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 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. 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 . What we are looking for This is what you will do The Clinical Data Innovation Manager 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. The 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. You will be responsible for Strategic Leadership Define and maintain the Clinical Data Innovation roadmap aligned with organizational objectives. Identify opportunities to leverage AI, machine learning, automation, and digital technologies across the clinical development lifecycle. Establish long-term strategies for clinical data architecture, interoperability, standardization, and data reuse. Serve as innovation ambassador within Clinical Development and across R&D. AI and Automation Lead 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 Develop frameworks and standard operating procedures for responsible and compliant AI use in accordance with company governance and regulatory expectations. Monitor emerging technologies and assess applicability to clinical development. Data Management Transformation Drive modernization of clinical data management processes and operating models. Lead initiatives to improve scalability and efficiency across internal and outsourced studies. Optimize interactions between Data Management, Programming, Biostatistics, Medical Writing, and Clinical Operations. Technology and Platform Leadership Act 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 Lead vendor evaluations and technology selection processes. Establish KPIs demonstrating technology value and business impact. Advanced Analytics and Insights Promote use of advanced analytics and visualization to improve study oversight. Enable near real-time monitoring of data quality, study conduct, operational performance and Risk indicators Partner with Biostatistics and Programming to enhance integrated data review capabilities. Innovation Management Build and manage a portfolio of innovation initiatives. Prioritize projects according to strategic value, feasibility, risk, and return on investment. Establish business cases and success metrics for innovation projects. Present innovation strategies and outcomes to senior leadership. Cross-Functional Collaboration Partner closely with stakeholders within R&D and related to R&D (i.e. Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Quality Assurance, IT) Build relationships with external vendors, technology providers, and industry consortia. Team and Capability Development Develop organizational capabilities in AI, automation, and innovative data practices. Mentor teams on emerging technologies and new ways of working. Foster a culture of experimentation, continuous improvement, and innovation. Contribute to workforce planning and future capability models. You will need to have Master’s degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Computer Science or related field. 10+ years of experience in the pharmaceutical, biotech or CRO industry, with strong exposure to clinical development. Solid experience in Clinical Data Management and the clinical trial data lifecycle. Proven experience in AI, automation, advanced analytics and/or digital innovation applied to clinical development. Experience with clinical data technologies, data architecture, interoperability and data standards. Strong cross-functional leadership experience across Clinical Development, Data Management, Biostatistics, Clinical Operations and IT/Digital. Proven track record of leading clinical data innovation and transformation initiatives, including vendor and technology management. Location Europe with hybrid or remote options. Compensation range The budgeted salary range approved for this role is between €59.000 and €74.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. The 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. 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 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.