Global In Vivo CAR-T Programs Lead

Legend Biotech EU; Maine; On-site; USD 256,000 - 336,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech USA Inc. seeks an Executive Director, Global Program Leader to shape and drive in vivo CAR-T programs from IND enabling through proof-of-concept and lifecycle management.

Reporting to the President of R&D, you will lead cross-functional teams across Clinical Development, Regulatory Affairs, Manufacturing, and Commercial to deliver integrated development plans and governance, ensuring timely milestones and strategic alignment.

Qualifications

• 10+ years of biotechnology or pharmaceutical industry experience in drug development
• 5+ years of leadership experience managing complex, global development programs
• Demonstrated success advancing biologics, cell therapies, gene therapies, or other advanced therapeutic programs
• Direct experience leading cross-functional development teams in a matrix environment
• Experience supporting global regulatory interactions and major regulatory submissions
• Experience in oncology, immunology, cell therapy, gene therapy, or in vivo genetic medicines strongly preferred

Responsibilities

• Lead the overall strategy and execution of assigned in vivo CAR-T programs across the development lifecycle
• Develop and maintain integrated global development plans that align scientific, clinical, regulatory, manufacturing, and commercial objectives
• Serve as the primary strategic leader and accountable executive for program success, key deliverables, timelines, budgets, and milestones
• Drive portfolio decision-making by evaluating benefit-risk profiles, competitive landscapes, development options, and investment priorities
• Ensure alignment of program strategies with corporate objectives and portfolio priorities
• Lead the formulation and execution of global clinical development and registration strategies for in vivo CAR-T assets
• Partner closely with Clinical Development and Regulatory Affairs to design efficient development pathways that maximize speed to proof-of-concept, pivotal development, and global approvals
• Guide critical regulatory interactions and major health authority milestones
• Ensure readiness and alignment for INDs, CTAs, BLA/MAA submissions, and lifecycle management activities
• Chair Global Program Teams and provide leadership across all functional areas involved in program execution
• Foster effective collaboration among Research, Translational Medicine, Clinical Development, Regulatory Affairs, Biometrics, CMC, Quality, Manufacturing, Commercial, Finance, and Business Development
• Drive cross-functional problem-solving and ensure timely resolution of strategic and operational risks
• Establish clear governance processes, decision frameworks, and accountability mechanisms
• Present program strategies, risks, and recommendations to executive leadership and governance committees
• Lead preparation of development scenarios, investment analyses, milestone recommendations, and portfolio reviews
• Provide regular updates to senior management on program status, emerging opportunities, and critical risks
• Ensure effective risk management and contingency planning throughout
• Represent Legend Biotech in interactions with external partners, collaborators, investigators, key opinion leaders, and other stakeholders
• Support business development assessments, diligence activities, and partnership opportunities related to in vivo CAR-T technologies
• Serve as a scientific and strategic ambassador for Legend’s in vivo CAR-T platformdevelopment
• Build a high-performance, patient-focused, and collaborative program culture
• Mentor and develop program management and cross-functional team members
• Champion innovation, accountability, and operational excellence across development teams

Skills

Leadership

Global program management

Cross-functional teams

Regulatory strategy

Executive communication

Biotech/pharma experience

CAR-T knowledge

Job description

Legend Biotech USA Inc. seeks an Executive Director, Global Program Leader to shape and drive in vivo CAR-T programs from IND enabling through proof-of-concept and lifecycle management.

Reporting to the President of R&D, you will lead cross-functional teams across Clinical Development, Regulatory Affairs, Manufacturing, and Commercial to deliver integrated development plans and governance, ensuring timely milestones and strategic alignment.