This is what you will doAn 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).You will be responsible forProgram Leadership & StrategyEnsure alignment and integration of all studies within the programContribute 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 teamsClinical Operations OversightOversee end‑to‑end Clinical Operations activitiesSupport CPMs on operational decisions and compliance (ICH‑GCP, SOPs)Contribute to study design, CPAC preparation, and feasibilityEnsure consistency across studies within the programDefine and oversee vendor/CRO strategiesSupport RFPs, evaluations, and Bid Defense MeetingsManage escalations and vendor governanceBudget OversightSupport planning, forecasting, and variance analysisAlign with CPMs and FinanceGovernance & Stakeholder ManagementParticipate in governance bodies (CPRF, PRM, XRC)Present program updates and risksFacilitate cross‑functional alignment and decision‑makingFunctional Leadership of CPMsProvide functional supervision and escalation supportCoach and support development (feedback, IDPs, objectives)Drive risk mitigation, CAPAs, and inspection readinessPromote quality and proactive risk managementClinical Documentation & Regulatory SupportSupport regulatory documentation (eCTD, CSR/CIR)Contribute to registry submissions and results communicationProcess ExcellenceSupport SOPs and continuous improvement initiativesEnsure compliance with required trainingYou will need to haveAdvanced degree in Life Sciences, Pharmacy, Medicine,



or a related scientific discipline.Significant experience in Clinical Operations within the pharmaceutical/biotechnology industry or CRO.Proven experience managing global clinical development programs across Early Phase, Late Phase, and Real‑World Evidence (RWE) studies.Strong understanding of clinical drug development processes and Clinical Development Plans (CDPs).Demonstrated ability to oversee multiple clinical studies within a complex development program.Experience coordinating cross‑functional teams and acting as a key interface between Clinical Operations and other development functions.Solid knowledge of ICH‑GCP guidelines, applicable regulatory requirements, and clinical research best practices.Experience in Clinical Research Organization (CRO) selection, oversight, and vendor management.Strong project and program management skills, including timeline development, milestone tracking, risk management, and budget oversight.Experience managing complex integrated project plans and clinical development timelines.Proven ability to provide strategic and operational guidance during protocol development and study planning.Experience preparing clinical documentation supporting regulatory submissions (e.G., eCTD components).Previous experience with functional leadership, mentoring, or matrix management of Clinical Project Managers or equivalent roles.Strong stakeholder management skills, with experience interacting with senior leadership and governance committees.Excellent communication, influencing, and presentation skills.Strong analytical and problem‑solving capabilities with the ability to make decisions in a complex environment.Ability to work effectively in a global, matrixed, and multidisciplinary organization.Fluency in English,



both written and spoken.We would prefer for you to haveExperience in Neonatology, Rare Diseases, Respiratory or Specialty Care therapeutic areas.Experience supporting global regulatory submissions.Previous participation in governance bodies and portfolio review committees.Experience in SOP development and process optimization initiatives.PMP, PRINCE2 or equivalent project management certification.Experience leading global outsourced clinical development models.LocationThis 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.Compensation rangeThe 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 toparticipatein an annual bonus scheme, subject to company and individual performance.In addition, we offer a comprehensive benefits package includingpension, private medical insurance, wellbeing programme, flexible benefits programme, buoni pasto and more.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.#J-18808-Ljbffr

📌 Clinical Operations Lead - €62.000 A Year (Parma)
🏢 Chiesi
📍 Parma