Clinical Project Management Director – Cell & Gene Therapy

Jobtailor; Durham (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Jobtailor in Durham, NC is seeking a senior leader to deliver large, complex global oncology studies and multi-study programs, translating customer objectives into operational strategies.

You will lead cross-functional teams across clinical operations, data management, safety, regulatory, and more, with a focus on CGT programs, risk management, and ensuring on-time delivery and quality.

Qualifications

• Extensive leadership in clinical research and oncology programs.
• Experience with CGT, CAR-T, TCR-T or ATMP programs preferred.
• Track record of managing executive-level stakeholder relationships.
• In-depth knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Lead delivery of large, complex global clinical studies and multi-study programs.
• Provide operational leadership across programs ensuring quality and milestones.
• Serve as senior sponsor contact, manage escalations and build relationships.
• Align global teams across clinical, data, safety, regulatory for seamless execution.
• Identify risks, implement mitigations and drive issue resolution.
• Oversee program finances, resource planning, forecasting and scope control.
• Contribute to proposals and bid defenses for large opportunities.
• Drive innovation, process optimization and best-practice implementation.
• Mentor project leaders and cross-functional staff.

Skills

Clinical Research Leadership

Oncology Therapeutic Expertise

Global Clinical Operations Management

Stakeholder Relationship Management

Strategic Planning and Risk Management

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

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

Job description

• 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