Clinical Operations Lead

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.

Our R&D 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, R&D 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).

An 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).

• Program 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
• Clinical 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
• Vendor & CRO Management
• Define and oversee vendor/CRO strategies
• Support RFPs, evaluations, and Bid Defense Meetings
• Manage escalations and vendor governance
• Budget Oversight
• Accountable for program-level budget
• Support planning, forecasting, and variance analysis
• Align with CPMs and Finance
• Governance & Stakeholder Management
• Participate in governance bodies (CPRF, PRM, XRC)
• Present program updates and risks
• Facilitate cross-functional alignment and decision-making
• Functional Leadership of CPMs
• Provide functional supervision and escalation support
• Coach and support development (feedback, IDPs, objectives)
• Risk & Inspection Readiness
• Drive risk mitigation, CAPAs, and inspection readiness
• Promote quality and proactive risk management
• Clinical Documentation & Regulatory Support
• Support regulatory documentation (eCTD, CSR/CIR)
• Contribute to registry submissions and results communication
• Process Excellence
• Support SOPs and continuous improvement initiatives
• Ensure compliance with required training

• Advanced 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 Clini