Legend Biotech is seeking Director, Preclinical Project Manager as part of the Early-stage Drug Development team based in Somerset, NJ.

Role Overview

The preclinical project manager 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 project timelines, budgets and regulatory requirements and acting as central point of communication between stakeholders to advance Legend drug development efforts.

Key Responsibilities

Project management
o Developing and manger project plans, timelines, budgets and resources for preclinical IND programs
o Coordinate and monitor preclinical studies, including in vitro and in vivo studies, ensuing alignment with program goals
o Track project progress, identify risks and implement mitigation strategies to maintain timelines and deliverables
Cross functional collaboration
o Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC, regulatory affairs) and eternal partners (e.g. CROs)
o Facilitate communication and collaboration among multidisciplinary teams to achieve project milestones
o regulatory and compliance
o Ensure preclinical studies comply with relevant regulatory guidelines (e.g., GLP, FDA, EMA).
o Prepare or support the creation of regulatory submissions, including pre-IND packages and investigator brochures.
Data Management and Reporting:
o Oversee data collection, analysis, and documentation for preclinical studies.
o Prepare project reports, presentations, and summaries for internal and external stakeholders.
Vendor and Budget Management:
o Identify, evaluate, and manage relationships with contract research organizations (CROs) and other external vendors.
o Negotiate contracts, oversee budgets, and ensure high-quality deliverables from external partners.
Strategic Input:
o Contribute to the design and development of preclinical study strategies to support clinical translation.
o 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, project management experience in pharmaceutical or biotech industry. Experience in IND submission of cell or therapies is preferred.
At least 10 years of relevant work experience, including a minimum of 5-8 years of preclinical research, project management experience in pharmaceutical or biotech industry. Experience in IND submission of cell or therapies is preferred
Familiarity with preclinical drug development processes, regulatory guidelines, and GLP standards.
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.
Proficiency in project management tools (e.g., MS Project, Asana) and data analysis software.
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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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.