Associate Director, Early Drug Development Project Manager

Legend Biotech US•Somerset, NJ

9d•Hybrid

About The Position

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 R&D 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 Associate Director, Early Drug Development 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.

Requirements

Ph.D. degree in life sciences, bioengineering, or related field required.
7 to 10 years of project/program management experience in biotechnology or pharmaceutical development including 3+ years directly supporting preclinical and/or early clinical development.
Strong understanding of drug development processes, including toxicology, nonclinical study design, CMC readiness, regulatory pathways, and early clinical operations.
Demonstrated track record managing complex, cross-functional programs spanning Research, Translational Science, CMC, Regulatory Affairs, and Clinical Operations.
Excellent organizational, communication, and stakeholder-management skills.
Experience with project management tools (e.g., MS Project, Smartsheet, Planisware).
Ability to identify risks early and drive pragmatic solutions.
Excellent English skills in written and oral.

Nice To Haves

Prior experience in cell therapy, gene therapy, or other advanced therapies strongly preferred.
Experience driving execution of IND-enabling studies, coordinating external CROs, and preparing teams for first-in-human or early-phase clinical trials.

Responsibilities

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.
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.
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.
Support preparation of IND-enabling documentation and regulatory submissions.
Track regulatory commitments within EDD.
Ensure project activities align with GxP and internal quality systems.
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.

Benefits

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume