Overview
The Clinical Program Lead is responsible for the strategic and operational oversight of interventional and/or non-interventional clinical studies within an assigned program. This role ensures high-quality, compliant, and efficient clinical trial delivery in line with ICH/GCP, regulatory requirements, and internal SOPs. Clinical Program Delivery
Study Execution & Oversight
- Lead end-to-end EU clinical programs from design through reporting
- Implement clinical program strategy and contribute to overall Clinical Affairs objectives
- Maintain holistic oversight of timelines, risks, quality, and budgets
- Proactively communicate progress, risks, and issues to senior leadership
- Drive cross-functional alignment and knowledge sharing
- Lead protocol development, applying Quality by Design principles
- Oversee study monitoring, ensuring data quality, integrity, and participant safety
- Supervise data management activities including cleaning and review
- Review analyses and lead Clinical Study Report (CSR) development
- Ensure inspection readiness and support GCP audits and regulatory inspections
Sites, Vendors & External Partners
- Oversee site selection, contracts, budgets, recruitment, and performance
- Manage relationships with investigators, expert physicians, and key opinion leaders
- Lead investigator meetings, site initiation, and accreditation activities
- Select and oversee CROs and service providers, ensuring performance against scope and quality expectations
Leadership & People Management
- Lead, coach, and mentor members of the Clinical Operations team
- Manage direct reports and support professional development initiatives
- Oversee resource planning and workload allocation within the program
- Support internal training and capability building
Program Enablement & Innovation
- Contribute to clinical process improvement and trial modernisation initiatives
- Support digital integration and operational efficiency across the portfolio
- Represent the company at conferences, external events, and regulatory meetings as required
Qualifications
- Graduate degree in Biological Sciences, Nursing, Pharmacy, or Medicine (postgraduate qualification desirable)
- Strong working knowledge of EU clinical trial regulations and ICH-GCP
- Proven experience managing EU clinical trials and clinical programs
- Experience overseeing data management and clinical reporting
- Demonstrated leadership and team management capability
- Strong project management, communication, and stakeholder engagement skills
- Ability to work independently and manage complex programs to tight timelines
Benefits
- Competitive salary and benefits package
- Opportunity to work alongside world-leading scientific experts
- High level of ownership and visibility within a growing global organisation
- Hands-on role contributing directly to therapies that improve patients' lives
- Hybrid working model
