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 ...
64 Quest Global Program Management Jobs Hiring Near You
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 ...
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Provide regular updates to senior management on program status, emerging opportunities, and ...
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Provide regular updates to senior management on program status, emerging opportunities, and ...
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Provide regular updates to senior management on program status, emerging opportunities, and ...
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Provide regular updates to senior management on program status, emerging opportunities, and ...
Global Program Director
Raleigh, NC · Hybrid
Manage Launch Readiness projects ensuring they achieve their intended targets, including leading the project team, updating R&D management on project status, ensuring up-to-date project data, and ...
Global Program Director
Raleigh, NC · Hybrid
Manage Launch Readiness projects ensuring they achieve their intended targets, including leading the project team, updating R&D management on project status, ensuring up-to-date project data, and ...
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Full-time
Re-posted yesterday
Key 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.
Job description
Legend Biotech is seeking an Executive Director, Global Program Leader as part of the Research & Development team based in Somerset, NJ.
Role Overview
The Executive Director, Global Program Leader (GPL) is a senior strategic leadership role responsible for the overall development, execution, and governance of Legend Biotech's in
vivo CAR-T programs.
Reporting directly to the President of R&D, the GPL serves as the single point of accountability for leading cross-functional teams to define and execute integrated global development strategies from IND enabling through clinical proof-of-concept, late-stage
development, registration, and lifecycle management. The GPL ensures alignment of program strategy, timelines, resources, and operational execution across Research, Clinical Development, Regulatory Affairs, Translational Sciences, Technical Development, Manufacturing, Commercial, Business Development, and other key functions.
The successful candidate will combine strong scientific and clinical development expertise with exceptional leadership, strategic thinking, and execution capabilities to advance innovative in vivo CAR-T therapies for patients worldwide.
Key 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 platform development.
- 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.
Requirements
- Minimum 10+ years of biotechnology or pharmaceutical industry experience in drug development.
- Minimum 5+ years of leadership experience managing complex, global development programs.
- Demonstrated success advancing biologics, cell therapies, gene therapies, or other advanced therapeutic programs through clinical development.
- 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.
- Deep understanding of global drug development, clinical development, and registration pathways.
- Strong knowledge of cell and gene therapy development, including emerging in vivo CAR-T technologies.
- Exceptional strategic thinking and portfolio management capabilities.
- Demonstrated ability to influence senior leaders and drive decisions in complex environments.
- Outstanding communication, presentation, and executive stakeholder management skills.
- Strong business acumen, financial awareness, and risk-management capabilities.
- Proven ability to lead diverse global teams and achieve ambitious development goals.
- Ability to operate effectively in a dynamic, fast-paced biotechnology environment.
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