OverviewIn this Clinical Operations Lead role, you will guide strategic and hands-on management of global clinical development programs across Early Phase, Late Phase and RWE studies.
You will align cross-functional teams within the Clinical Development Plan and mentor Clinical Project Managers.
You'll oversee end-to-end operations, manage budgets and vendors, and drive risk and quality governance.
This is a chance to shape programs at a financially responsible, highly collaborative biopharma group with a strong patient focus.
Retribuzione / Benefitsannual premio scheme
pension
private medical insurance
wellbeing programme
flexible benefits programme
remote work options
ResponsabilitàLead program strategy and ensure study alignment within the program
Contribute to Clinical Development Plan feasibility, timelines, geographic strategy, and budget
Maintain integrated timelines and milestones including go/no-go decisions
Serve as primary Clinical Operations interface for cross-functional teams
Oversee end-to-end Clinical Operations activities
Support CPMs on operational decisions and compliance (ICH-GCP, SOPs)
Contribute to study design and feasibility assessments (CPAC)
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
Accountable for program-level budget with planning, forecasting, and variance analysis
Participate in governance bodies and present updates/risks
Provide functional supervision and escalation support to CPMs
Coach and develop CPMs (IDPs, objectives)
Drive risk mitigation, CAPAs,



and inspection readiness
Support regulatory documentation (eCTD, CSR/CIR) and registry submissions
Support SOPs and continuous improvement initiatives
Ensure compliance with required training
Requisiti fondamentaliAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Significant experience in Clinical Operations in pharma/biotech or CRO
Proven experience managing global clinical development programs across Early Phase, Late Phase and RWE
Strong understanding of CDPs and clinical development processes
Experience coordinating cross-functional teams and acting as key interface between Clinical Operations and other functions
Solid knowledge of ICH-GCP guidelines and regulatory requirements
Experience in CRO selection, oversight, and vendor management
Strong project/program management skills with timelines, milestones, risk management, and budget oversight
Experience managing complex integrated project plans and development timelines
Proven ability to provide strategic and operational guidance in protocol development and study planning
Experience preparing clinical documentation for regulatory submissions (eCTD components)
Past experience with functional leadership or matrix management of CPMs
Strong stakeholder management and presentation skills
Excellent communication, analytical, and problem-solving abilities
Ability to work in a global, matrixed, multidisciplinary organization
Fluency in English (written and spoken)
strong communication
influencing and presentation skills
leadership and mentoring
ICH-GCP
CDP planning
vendor/CRO management

📌 Clinical Operations Lead (Novara)
🏢 Chiesi
📍 Novara