ppSelect how often (in days) to receive an alert: /ppBusiness Area: RD, Pharmacovigilance Regulatory Affairs /ppJob Type: Direct Employee /ppContract Type: Permanent /ppLocation: Italy remote, IT /ppbAbout us /b /ppChiesi 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. /ppAt 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. /ppDiversity 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. /ppbChiesi Research Development /b /ppOur RD team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, RD project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). /ppbWho we are looking for /b /ph3bThis is what you will do /b /h3pAn experienced Clinical Operations Lead with a strong background in global drug development, capable of providing strategic and operational leadership across complex clinical development programs. The Clinical Operations Lead (COL) ensures the integration and continuity of Clinical Operations activities across Early Phase, Late Phase and Real-World Evidence (RWE) studies, acting as the operational representative within the Clinical Development Plan (CDP) team and as functional leader of Clinical Project Managers (CPMs). /ph3bYou will be responsible for /b /h3pbProgram Leadership Strategy /b /pulliEnsure alignment and integration of all studies within the program /liliContribute to the Clinical Development Plan (feasibility, timelines, geographic strategy, budget) /liliMaintain overall operational oversight, integrated timelines, and key milestones (incl. go/no-go)



/liliAct as primary Clinical Operations interface for cross-functional teams /li /ulpbClinical Operations Oversight /b /pulliOversee end-to-end Clinical Operations activities /liliSupport CPMs on operational decisions and compliance (ICH-GCP, SOPs) /liliContribute to study design, CPAC preparation, and feasibility /liliEnsure consistency across studies within the program /liliDefine and oversee vendor/CRO strategies /liliSupport RFPs, evaluations, and Bid Defense Meetings /liliManage escalations and vendor governance /li /ulpbBudget Oversight /b /pulliSupport planning, forecasting, and variance analysis /liliAlign with CPMs and Finance /li /ulpbGovernance Stakeholder Management /b /pulliParticipate in governance bodies (CPRF, PRM, XRC) /liliPresent program updates and risks /liliFacilitate cross-functional alignment and decision-making /li /ulpbFunctional Leadership of CPMs /b /pulliProvide functional supervision and escalation support /liliCoach and support development (feedback, IDPs, objectives) /liliDrive risk mitigation, CAPAs, and inspection readiness /liliPromote quality and proactive risk management /li /ulpbClinical Documentation Regulatory Support /b /pulliSupport regulatory documentation (eCTD, CSR/CIR) /liliContribute to registry submissions and results communication /li /ulpbProcess Excellence /b /pulliSupport SOPs and continuous improvement initiatives /liliEnsure compliance with required training /li /ulh3bYou will need to have /b /h3ulliAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline. /liliSignificant experience in Clinical Operations within the pharmaceutical/biotechnology industry or CRO. /liliProven experience managing global clinical development programs across Early Phase, Late Phase, and Real-World Evidence (RWE) studies. /liliStrong understanding of clinical drug development processes and Clinical Development Plans (CDPs). /liliDemonstrated ability to oversee multiple clinical studies within a complex development program. /liliExperience coordinating cross-functional teams and acting as a key interface between Clinical Operations and other development functions. /liliSolid knowledge of ICH-GCP guidelines, applicable regulatory requirements, and clinical research best practices. /liliExperience in Clinical Research Organization (CRO) selection, oversight, and vendor management. /liliStrong project and program management skills, including timeline development, milestone tracking, risk management, and budget oversight. /liliExperience managing complex integrated project plans and clinical development timelines. /liliProven ability to provide strategic and operational guidance during protocol development and study planning. /liliExperience preparing clinical documentation supporting regulatory submissions (e.g., eCTD components). /liliPrevious experience with functional leadership, mentoring,



or matrix management of Clinical Project Managers or equivalent roles. /liliStrong stakeholder management skills, with experience interacting with senior leadership and governance committees. /liliExcellent communication, influencing, and presentation skills. /liliStrong analytical and problem-solving capabilities with the ability to make decisions in a complex environment. /liliAbility to work effectively in a global, matrixed, and multidisciplinary organization. /liliFluency in English, both written and spoken. /li /ulh3bWe would prefer for you to have /b /h3ulliExperience in Neonatology, Rare Diseases, Respiratory or Specialty Care therapeutic areas. /liliExperience supporting global regulatory submissions. /liliPrevious participation in governance bodies and portfolio review committees. /liliExperience in SOP development and process optimization initiatives. /liliPMP, PRINCE2 or equivalent project management certification. /liliExperience leading global outsourced clinical development models. /li /ulh3bLocation /b /h3pThis position is based at our HQ in Parma, Italy, with flexibility for either a hybrid working arrangement or a predominantly remote setup, depending on the candidate's location and experience. /ph3bCompensation range /b /h3pThe minimum salary for this role is €62.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /ppThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /ppIn addition, we offer a comprehensive benefits package includingpension, private medical insurance, wellbeing programme, flexible benefits programme, buoni pasto and more. /ppbWhat we offer /b /ppNo 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. /ppWe 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. /ppChiesi 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 /p #J-18808-Ljbffr

📌 Clinical Operations Lead (Italia)
🏢 Chiesi Farmaceutici
📍 Italia