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Job Description
Legend Biotech is seeking a Director, Preclinical Project Manager to join their Early-stage Drug Development team. This role is based in Somerset, NJ. The Director will be responsible for planning, executing, and overseeing preclinical development projects. They will manage a cross-functional team, ensure adherence to timelines and budgets, and act as a central communication point.
Role Involves:
- Developing and managing project plans, timelines, and budgets.
- Coordinating and monitoring preclinical studies.
- Serving as a liaison between internal departments and external partners.
- Ensuring compliance with regulatory guidelines.
- Overseeing data collection, analysis, and documentation.
- Managing relationships with CROs and other external vendors.
- Contributing to the design and development of preclinical study strategies.
Requirements:
- PhD in biology and biochemistry or related field.
- At least 10 years of relevant work experience, including 5-8 years in preclinical research and project management in the 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.
- Excellent communication and interpersonal skills.
- Proficiency in project management tools and data analysis software.
- Knowledge of regulatory requirements and preclinical study design principles.
- Experience working with CROs and managing external collaborations.
- Certification in project management (e.g., PMP, PRINCE2) is a plus.
What This Role Offers:
- Opportunity to work on preclinical development projects at Legend Biotech.
- Chance to manage cross-functional teams and collaborate with internal and external stakeholders.
- Involvement in regulatory submissions and ensuring compliance with guidelines.
- Opportunity to contribute to the design and development of preclinical study strategies.
