ph3bThis is what you will do /b /h3 pAn 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). /p h3bYou will be responsible for /b /h3 pbProgram Leadership Strategy /b /p ulliEnsure 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 /ul pbClinical Operations Oversight /b /p ulliOversee 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 /ul pbBudget Oversight /b /p ulliSupport planning, forecasting, and variance analysis /liliAlign with CPMs and Finance /li /ul pbGovernance Stakeholder Management /b /p ulliParticipate in governance bodies (CPRF, PRM, XRC) /liliPresent program updates and risks /liliFacilitate cross‑functional alignment and decision‑making /li /ul pbFunctional Leadership of CPMs /b /p ulliProvide 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 /ul pbClinical Documentation Regulatory Support /b /p ulliSupport regulatory documentation (eCTD, CSR/CIR)



/liliContribute to registry submissions and results communication /li /ul pbProcess Excellence /b /p ulliSupport SOPs and continuous improvement initiatives /liliEnsure compliance with required training /li /ul h3bYou will need to have /b /h3 ulliAdvanced 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 /ul h3bWe would prefer for you to have /b /h3 ulliExperience 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 /ul h3bLocation /b /h3 pThis 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. /p h3bCompensation range /b /h3 pThe 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. /p pThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package includingpension, private medical insurance, wellbeing programme, flexible benefits programme, buoni pasto and more. /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 /p #J-18808-Ljbffr

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