Overview
In 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 / Benefits
- annual bonus scheme
- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- remote work options
Responsabilità
- Lead 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 fondamentali
- Advanced 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 datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
