Early Stage Drug Development Project Manager
Company: Legend Biotech
Location: Somerset
Posted on: March 19, 2026
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Job Description:
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 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. 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 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. Decision Making Have the
ability to drive project timeline Requirements 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,
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. Li-JR1 Li-Hybrid The base pay range below is
what Legend Biotech USA Inc. reasonably expects to offer at the
time of posting. Actual compensation may vary based on experience,
skills, qualifications, and geographic location. The company
reserves the right to modify this range as needed and in accordance
with applicable laws. Other Types of Pay: Performance-based bonus
and/or equity is available to employees in eligible roles. Benefits
and Paid Time Off: 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. Pay Range (Base Pay): $93,463 - $122,670 USD
Please note: These benefits are offered exclusively to permanent
full-time employees. Contractors are not eligible for benefits
through Legend Biotech. EEO Statement It is the policy of Legend
Biotech to provide equal employment opportunities without regard to
actual or perceived race, color, creed, religion, national origin,
ancestry, citizenship status, age, sex or gender (including
pregnancy, childbirth, related medical conditions and lactation),
gender identity or gender expression (including transgender
status), sexual orientation, marital status, military service and
veteran status, disability, genetic information, or any other
protected characteristic under applicable federal, state or local
laws or ordinances. Employment is at-will and may be terminated at
any time with or without cause or notice by the employee or the
company. For information related to our privacy notice, please
review: Legend Biotech Privacy Notice .
Keywords: Legend Biotech, Norwalk , Early Stage Drug Development Project Manager, Science, Research & Development , Somerset, Connecticut