Clinical Program Leader

Key Responsibilities

Clinical Program Leadership

• Lead global and European clinical programs across a rare disease portfolio from planning through execution and study completion.
• Drive program delivery, ensuring alignment with broader clinical development and corporate objectives.
• Maintain oversight of timelines, budgets, quality metrics, risk management, and overall program performance.
• Provide regular strategic updates and recommendations to senior leadership and governance committees.
• Coordinate and lead cross-functional teams across Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Drug Safety, and external partners.
• Support the progression of rare disease indications through key development milestones and toward approval.

Clinical Execution & Delivery

• Ensure operational excellence across all stages of clinical trial delivery.
• Provide oversight of study conduct, patient safety, data integrity, and regulatory compliance.
• Support protocol development and implementation of Quality by Design principles.
• Review clinical data, study progress, and key performance indicators to drive informed decision-making.
• Lead study reporting activities, CSR development, and support regulatory submissions.
• Maintain inspection readiness and oversee audit preparation and regulatory interactions.

Cross-Functional Leadership

• Lead multidisciplinary project teams to deliver program objectives efficiently and effectively.
• Foster strong collaboration between internal functions and external stakeholders.
• Drive accountability and alignment across all program contributors.
• Act as a key clinical representative during governance meetings and strategic planning discussions.
• Build strong working relationships with investigators, KOLs, CROs, and vendors.

Site & Vendor Oversight

• Oversee site feasibility, site selection, contracting, budgets, recruitment, and operational performance.
• Lead vendor selection, governance, and performance management activities.
• Ensure CROs and service providers deliver against agreed timelines and quality expectations.
• Support investigator engagement, site training initiatives, and study-related meetings.
• Provide guidance and oversight to Clinical Study Leads and Clinical Project Associates.

Leadership & Team Development

• Provide leadership, coaching, and mentorship across clinical teams.
• Support resource planning and allocation across programs.
• Develop team capabilities through training, knowledge sharing, and best practice initiatives.
• Foster a culture of continuous improvement, collaboration, and operational excellence.
• Contribute to the ongoing growth and development of the Clinical Affairs function.

Innovation & Continuous Improvement

• Identify opportunities to enhance clinical trial execution and program efficiency.
• Support implementation of innovative approaches, technologies, and digital solutions.
• Drive process improvements across the clinical development organisation.
• Contribute to external scientific and clinical communications where appropriate.
• Represent the organisation at industry meetings, conferences, and regulatory interactions.