Legend Biotech · 1 hour ago
Director, Preclinical Project Development and Strategic Lead
Somerset, NJ
Full-time
Onsite
Director/Executive
$188K/yr - $247K/yr
10+ years expLegend Biotech is a global biotechnology company focused on developing advanced cell therapies for life-threatening diseases. They are seeking a Director, Preclinical Project Development and Strategic Lead to oversee preclinical development projects, manage cross-functional teams, and ensure compliance with regulatory requirements. This role involves strategic planning, project management, and collaboration with various internal and external stakeholders.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Hiring Manager
Justin Kerno
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 manage project plans, timelines, budgets and resources for preclinical IND programs
Coordinate and monitor preclinical studies, including in vitro and in vivo studies, ensuring 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 external 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
Qualification
Required
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
Preferred
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
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase