Director, Preclinical Project Development and Strategic Lead

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 a Director, Preclinical Project Development and Strategic Lead as part of the Early-stage Drug Development team based in Somerset, NJ. 

Role Overview

The Preclinical development and strategic lead is responsible for planning, executing and overseeing preclinical development projects of Legend. He or she will be responsible for managing cross-functional team, ensuring adherence to IND submission timelines, budgets and regulatory requirements and acting as central point of communication between stakeholders to advance Legend drug development efforts. 

Key Responsibilities  

• Preclinical IND enabling study oversight
  • Work closely with program teams to develop preclinical IND strategies. Accountable for preclinical IND study delivery and quality
  • Developing and mange project plans, timelines, budgets and resources for preclinical IND programs
  • Coordinate and monitor preclinical studies, including in vitro and in vivo studies, ensuing alignment with program goals
  • Track project progress, identify risks and implement mitigation strategies to maintain timelines and deliverables
• Cross functional collaboration
  • Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC, regulatory affairs) and eternal partners (e.g. CROs)
  • Facilitate communication and collaboration among multidisciplinary teams to achieve project milestones
  • Ensure preclinical studies comply with relevant regulatory guidelines (e.g., GLP, FDA, EMA).
  • Prepare or support the creation of regulatory submissions, including pre-IND packages and investigator brochures.
• Data Management and Reporting:
  • Oversee data collection, analysis, and documentation for preclinical studies.
  • Prepare project reports, presentations, and summaries for internal and external stakeholders.
• Vendor and Budget Management:
  • Identify, evaluate, and manage relationships with contract research organizations (CROs) and other external vendors.
  • Negotiate contracts, oversee budgets, and ensure high-quality deliverables from external partners.
• Strategic Input:
  • Contribute to the design and development of preclinical study strategies to support clinical translation.
  • Provide input on program development based on emerging data and scientific trends.
    

Requirements

• PhD in biology and biochemistry or related field
• At least 10 years of relevant work experience, including a minimum of 5-8 years of preclinical research and development experience in pharmaceutical or biotech industry. Experience in IND submission of cell or therapies.
• Familiarity with preclinical drug development processes, regulatory guidelines, and GLP standards.
• Preclinical project lead in IND submission
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills for cross-functional collaboration and stakeholder engagement.
• Knowledge of regulatory requirements and preclinical study design principles
• Experiences in preclinical research especially in cell therapy preclinical development is preferred
• Experience working with CROs and managing external collaborations.
• Certification in project management (e.g., PMP, PRINCE2) is a plus.

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The anticipated base pay range is:$187,989—$246,737 USD

Benefits:

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