Early Stage Drug Development Project Manager

Early Stage Drug Development Project Manager

Somerset, New Jersey, United States

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.

We are seeking a seasoned Project Manager to support preclinical and early clinical development  successful candidate will oversee and coordinate cross‑functional efforts related to preclinical research and the advancement of cell therapy products through early clinical stages. This position is responsible for ensuring that all programs progress according to timelines, remain within scope, and comply with regulatory, quality, and scientific standards.

The Project Manager will collaborate extensively with Research, Translational Science, CMC, Regulatory Affairs, Clinical Operations, Quality, and external stakeholders to facilitate execution from late‑stage discovery through IND‑enabling studies and early‑phase clinical trials.

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 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.
• 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.

Decision Making

• Have the ability to drive project timeline.

• Bachelor’s degree in life sciences, bioengineering, or related field required.
• Advanced degree (MS, PhD) preferred.
• 3–7+ years of project management experience in biotechnology or pharmaceutical development.
• Hands‑on experience supporting preclinical and/or early clinical development programs.
• Experience in cell therapy, gene therapy, or other advanced therapies strongly preferred.
• Familiarity with IND‑enabling studies and early‑phase clinical development.
• Strong understanding of drug development processes, especially for cell‑based therapies.
• Proven ability to manage complex,…