EDD Project Manager

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an EDD Project Manager as part of the Early Drug Development team based in Somerset, NJ . Role Overview We are seeking a seasoned Project Manager to support preclinical and early clinical development at Legend. The successful candidate will be responsible for driving cross-functional planning, execution, and delivery of early-stage development programs at Legend. This role provides project leadership across late-discovery, IND-enabling, and early clinical development stages, ensuring programs advance efficiently, on time, and in alignment with regulatory and quality standards. The Project Manager will serve as a strategic partner to Research, Translational Science, CMC, Regulatory Affairs, Clinical Operations, Quality, and external stakeholders. The role influences decision-making, ensures alignment across stakeholders, and maintains high execution rigor while supporting portfolio-level needs within the Preclinical and Early Drug Development organization.. Key Responsibilities Program Project Management Working closely with project lead, develop and maintain integrated project plans for Project team covering preclinical, CMC, regulatory, and early clinical activities. Drive the strategic planning of early-stage programs, ensuring alignment with portfolio priorities and organizational objectives. Drive execution of program timelines, milestones, budgets, and resource plans. Track deliverables, identify risks, and implement mitigation strategies. Facilitate governance meetings, project team meetings, and decision-making forums. Prepare clear project status updates, dashboards, and executive-level reports. Preclinical Translational Development Coordinate in vitro and in vivo studies, including pharmacology, toxicology, biodistribution, and tumorigenicity (as applicable). Manage interactions with CROs and academic collaborators conducting preclinical studies. Ensure studies are conducted in alignment with regulatory expectations for IND submissions. Support data integration and readiness for regulatory filings and internal reviews. Early Clinical Development Support Support planning and execution of first-in-human and early-phase (Phase 1/1b) clinical studies. Coordinate cross-functional inputs for clinical trial readiness (clinical operations, CMC, QA, regulatory). Assist with clinical timelines, site activation planning, and investigational product readiness. Regulatory Quality Interface Support preparation of IND-enabling documentation and regulatory submissions. Track regulatory commitments within EDD. Ensure project activities align with GxP and internal quality systems. Vendor Stakeholder Management Manage external vendors, CROs, and consultants, including scope, timelines, and deliverables. Foster effective collaboration across internal teams and external partners. Serve as a central point of communication for program execution. Has the ability to drive project timeline. Requirements Ph.D. degree in life sciences, bioenginee ... (truncated, view full listing at source)