ppDescrizione dell’offerta di lavoro /p h3About us /h3 pChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. /p pMore than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. /p pThis is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. /p pDiscover more here.At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. /p pThis fosters a culture of reliability, transparency, and ethical behaviour at every level. /p pAs a Benefit 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. /p pWe believe our differences make us stronger. /p pWe 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 h3Chiesi Research Development /h3 pOur RD team represents a fundamental asset for the business. /p pIt 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. /p pHeadquartered 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). /p h3Who we are looking for /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. /p h3Responsibilities /h3 ul liProgram Leadership Strategy: Ensure alignment and integration of all studies within the program. Contribute to the Clinical Development Plan (feasibility, timelines, geographic strategy, budget). Maintain overall operational oversight, integrated timelines, and key milestones (incl. go/no-go). Act as primary Clinical Operations interface for cross-functional teams. /li liClinical Operations Oversight: Oversee end-to-end Clinical Operations activities. Support CPMs on operational decisions and compliance (ICH-GCP, SOPs). Contribute to study design, CPAC preparation, and feasibility. Ensure consistency across studies within the program. /li liVendor CRO Management: Define and oversee vendor/CRO strategies. Support RFPs, evaluations, and Bid Defense Meetings.



Manage escalations and vendor governance. /li liBudget Oversight: Accountable for program-level budget. Support planning, forecasting, and variance analysis. Align with CPMs and Finance. /li liGovernance Stakeholder Management: Participate in governance bodies (CPRF, PRM, XRC). Present program updates and risks. Facilitate cross-functional alignment and decision-making. /li liFunctional Leadership of CPMs: Provide functional supervision and escalation support. Coach and support development (feedback, IDPs, objectives). /li liRisk Inspection Readiness: Drive risk mitigation, CAPAs, and inspection readiness. Promote quality and proactive risk management. /li liClinical Documentation Regulatory Support: Support regulatory documentation (eCTD, CSR/CIR). Contribute to registry submissions and results communication. /li liProcess Excellence: Support SOPs and continuous improvement initiatives. Ensure compliance with required training. /li liOther responsibilities: support regulatory submissions, governance bodies, SOP development, process optimisation, global outsourced clinical development models. /li /ul h3Requirements /h3 ul liAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline. /li liSignificant experience in Clinical Operations within the pharmaceutical/biotechnology industry or CRO. /li liProven experience managing global clinical development programs across Early Phase, Late Phase, and Real-World Evidence (RWE) studies. /li liStrong understanding of clinical drug development processes and Clinical Development Plans (CDPs). /li liDemonstrated ability to oversee multiple clinical studies within a complex development program. /li liExperience coordinating cross-functional teams and acting as a key interface between Clinical Operations and other development functions. /li liSolid knowledge of ICH-GCP guidelines, applicable regulatory requirements, and clinical research best practices. /li liExperience in Clinical Research Organization (CRO) selection, oversight, and vendor management. /li liStrong project and program management skills, including timeline development, milestone tracking, risk management, and budget oversight. /li liExperience managing complex integrated project plans and clinical development timelines. /li liProven ability to provide strategic and operational guidance during protocol development and study planning.



/li liExperience preparing clinical documentation supporting regulatory submissions (e.g., eCTD components). /li liPrevious experience with functional leadership, mentoring, or matrix management of Clinical Project Managers or equivalent roles. /li liStrong stakeholder management skills, with experience interacting with senior leadership and governance committees. /li liExcellent communication, influencing, and presentation skills. /li liStrong analytical and problem-solving capabilities with the ability to make decisions in a complex environment. /li liAbility to work effectively in a global, matrixed, and multidisciplinary organization. /li liFluency in English, both written and spoken. /li liPreferred: Experience in Neonatology, Rare Diseases, Respiratory or Specialty Care therapeutic areas. /li liExperience supporting global regulatory submissions. /li liPrevious participation in governance bodies and portfolio review committees. /li liExperience in SOP development and process optimization initiatives. /li liPMP, PRINCE2 or equivalent project management certification. /li liExperience leading global outsourced clinical development models. /li /ul h3Location /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 h3Compensation /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. This role is eligible to participate in an annual premio scheme, subject to company and individual performance. /p h3Benefits /h3 ul lipension /li liprivate medical insurance /li liwellbeing programme /li liflexible benefits programme /li liticket restaurant /li limore /li licomprehensive healthcare programs /li liwork-life balance initiatives /li lirobust relocation support /li lisalary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. /li liflexible working arrangements /li liremote work options /li litax assistance services for foreign colleagues /li /ul h3Equal Opportunity Statement /h3 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 (Spoleto)
🏢 Chiesi
📍 Spoleto