Jobs · Project Management · Kansas

Clinical Program Leader

EPM Scientific · Burlingame, KS · 1 wk ago
HybridProject ManagementFull-time

About the role

This is a strategic Clinical Program Lead position within the Global Clinical Affairs function, responsible for overseeing the delivery of European clinical programs and supporting the broader clinical development strategy.

Key Responsibilities

  • Lead the delivery of clinical programs across Europe from planning through study completion.

  • Implement program strategy in alignment with wider clinical development objectives.

  • Maintain oversight of timelines, budget, quality, risks, and program performance.

  • Provide regular updates to senior stakeholders on program progress and key challenges.

  • Drive collaboration across Clinical Operations, Medical Affairs, Regulatory Affairs, and external partners.

Study Design & Execution

  • Contribute to protocol development and implementation of Quality by Design principles.

  • Oversee study conduct to ensure data integrity, participant safety, and regulatory compliance.

  • Support study monitoring activities and oversee data review and cleaning processes.

  • Lead reporting activities, data analysis review, and Clinical Study Report development.

  • Maintain a high level of inspection readiness and support audits and regulatory inspections.

Site & Vendor Management

  • Oversee site selection, contracting, budgets, recruitment, and operational performance.

  • Build strong relationships with investigators, physicians, and external experts.

  • Lead investigator meetings, site engagement activities, and study-related training.

  • Select and manage CROs, service providers, and external vendors to ensure delivery against programme objectives.

  • Support Clinical Study Leads and Clinical Project Associates in study execution and oversight.

Leadership & Team Development

  • Provide leadership, coaching, and mentorship to study management teams.

  • Manage and develop Clinical Operations personnel, including direct reports.

  • Support professional development initiatives across the Clinical Affairs group.

  • Lead resource planning and allocation within assigned programs.

  • Deliver internal training and knowledge-sharing initiatives.

Innovation & Continuous Improvement

  • Drive process improvement initiatives to enhance study execution and portfolio efficiency.

  • Support modernisation of clinical trials through digital integration and innovation.

  • Promote knowledge transfer and best practice across clinical teams.

  • Support development of external clinical communications.

  • Represent the organisation at conferences, industry meetings, and regulatory interactions.

Candidate Profile

  • Degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related scientific discipline.

  • Proven experience managing clinical trials and clinical programs across Europe.

  • Strong knowledge of ICH-GCP and international clinical research regulations.

  • Experience overseeing complex, cross-functional clinical development activities.

  • Working knowledge of clinical data management and study reporting.

  • Strong project management and organisational skills.

  • Excellent communication and stakeholder management capabilities.

  • Demonstrated leadership experience with the ability to guide and develop teams.

  • Strong analytical, problem-solving, and decision-making skills.

  • Ability to thrive in a fast-paced, evolving biotechnology environment.

Why Join

  • High-impact leadership position with broad program ownership.

  • Opportunity to influence clinical development strategy and execution.

  • Exposure to senior leadership and external stakeholders.

  • Collaborative environment working alongside leading scientific experts.

  • Fast-growing organisation offering significant career development opportunities.

  • Competitive salary, benefits package, and flexible hybrid working model.

Location & Package

West London, United Kingdom
Hybrid working model
Permanent, full-time position
Competitive salary and benefits package

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