Associate Director, Early Drug Development Project Manager

Описание вакансии

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 Manageras 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, 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.
• 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.
• 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.

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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):

$142,146—$186,567 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.