Clinical Project Management Director – Cell & Gene Therapy

• Lead the delivery of large, complex global clinical studies and multi-study programs, translating customer objectives into effective operational strategies and execution plans


• Provide operational leadership across programs and portfolios, ensuring consistency, quality, financial performance and successful delivery of clinical milestones


• Serve as the primary senior contact for sponsors, building trusted relationships, managing escalations and driving collaborative solutions to achieve shared goals


• Lead and align global, matrixed teams across clinical operations, data management, safety, regulatory and other functional areas to ensure seamless execution


• Proactively identify operational and strategic risks, implement mitigation plans and lead issue resolution efforts to maintain project momentum and performance


• Oversee program financial performance, resource planning, forecasting, scope management and change control activities to support successful business outcomes


• Contribute to proposal development, strategic planning and bid defense activities for large, multi-service clinical opportunities


• Drive innovation, process optimization, and the implementation of best practices to enhance delivery efficiency, quality and customer satisfaction


• Mentor and develop project leaders and cross-functional team members, fostering a culture of accountability, collaboration and professional growth

Requirements

• 12-15+ years of experience in clinical research, clinical operations, and/or project leadership within the pharmaceutical, biotechnology, or CRO industry


• Deep oncology therapeutic expertise is required, with a strong preference for experience leading Cell & Gene Therapy (CGT), CAR-T, TCR-T, gene editing or other Advanced Therapy Medicinal Product (ATMP) programs


• Demonstrated success leading complex global oncology portfolios and building trusted relationships with executive-level stakeholders


• Proven success leading large, global, multi-regional clinical studies, programs or portfolios with operational and financial responsibility


• Strong understanding of clinical trial conduct, ICH-GCP guidelines and applicable regulatory requirements


• Demonstrated ability to build and maintain executive-level customer relationships and successfully manage complex stakeholder environments


• Experience leading matrixed, cross-functional teams in a global environment


• Strong strategic thinking, problem-solving and risk management capabilities


• Excellent communication, presentation and influencing skills


• Bachelor's degree in Life Sciences or a related field required; advanced degree preferred.

Core Competencies

Demonstrates extensive experience in leading complex global clinical studies and programs, with a strong focus on oncology and advanced therapy medicinal products. Proven ability to build executive-level relationships and drive operational excellence through strategic planning and risk management.

Highest-signal resume keywords

• Clinical Research Leadership


• Oncology Therapeutic Expertise


• Global Clinical Operations Management


• Stakeholder Relationship Management


• Strategic Planning and Risk Management

ATS Optimization Keywords

Hard Skills

• Clinical Trial Conduct


• ICH-GCP Guidelines


• Program Financial Performance


• Resource Planning


• Change Control Activities


• Proposal Development


• Process Optimization


• Operational Strategy Development


• Multi-Regional Study Management


• Advanced Therapy Medicinal Products

Soft Skills

• Excellent Communication


• Presentation Skills


• Influencing Skills


• Problem-Solving


• Collaboration

Industry Keywords

• Pharmaceutical Industry


• Biotechnology


• CRO Industry


• Cell & Gene Therapy


• CAR-T


• TCR-T


• Gene Editing


• Clinical Operations


• Matrixed Teams


• Executive-Level Stakeholders