Clinical Operations Lead

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Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Italy remote, IT

About us

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.

Chiesi Research & Development

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).

Who we are looking for

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
• Define and oversee vendor/CRO strategies
• Support RFPs, evaluations, and Bid Defense Meetings
• Manage escalations and vendor governance

Budget Oversight

• 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)
• 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 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.

• Experience 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.

This 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.

The 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, ticket restaurant and more.

What we offer

No 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.

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.