Early Stage Drug Development Project Manager

Legend Biotech US • Somerset, NJ

6h • Hybrid

About The Position

Legend Biotech is seeking an Early Stage Drug Development Project Manager as part of the Early-Stage 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 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. Legend remains dedicated to developing innovative cell therapy solutions aimed at addressing unmet medical needs. As a member of the Preclinical and Early Clinical Development team, the Project Manager will be integral to fostering effective collaboration and driving efficient advancement of research initiatives.

Requirements

• Bachelor’s degree in life sciences, bioengineering, or related field required.
• 3–7+ years of project management experience in biotechnology or pharmaceutical development.
• Hands-on experience supporting preclinical and/or early clinical development programs.
• 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, cross-functional programs in a fast-paced environment.
• 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.

Nice To Haves

• Advanced degree (MS, PhD) preferred.
• Experience in cell therapy, gene therapy, or other advanced therapies strongly preferred.

Responsibilities

• 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.
• 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.
• Have 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager