VP, Head of Preclinical Development
$294.48k - $386.51kLegend Biotech USA, Inc.
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 VP, Head of Preclinical Development as part of the Early Drug Development team based in Somerset, NJ . Role Overview Legend Biotech is a clinical-stage biotech company developing cell therapies for hematological malignancies, solid tumors and autoimmune diseases. We are seeking an exceptional scientist-leader to serve as Vice President, Head of Preclinical Development. This is a senior, externally visible leadership role accountable for the full preclinical development program across in vitro pharmacology, in vivo pharmacology, and toxicology for all pipeline compounds globally. The person will build and lead a high-performing, integrated team, set scientific standards for the organization, and serve as the internal authority and external face for preclinical science across regulatory, partnership, and publication contexts. Key Responsibilities
- Define and execute the preclinical development strategy across all pipeline program globally from candidate nomination through IND-enabling studies.
- Serve as the internal scientific authority on in vitro pharmacology, in vivo pharmacology, and toxicology - setting methodological standards, experimental design principles, and data interpretation frameworks.
- Lead preclinical science for novel modalities including lentiviral vector-based in vivo CAR-T, ex vivo cell therapies, and gene-modified immune cell platforms, with deep understanding of the unique preclinical characterization requirements of each
- Integrate preclinical datasets (PK, PD, safety, biodistribution etc) into coherent compound narratives that inform clinical development strategy, dose selection, and regulatory submissions.
- Contribute to portfolio decisions by providing rigorous preclinical risk assessments for new candidates, partnership assets, and lifecycle management opportunities.
- Own the preclinical component of IND applications, accountable for integrated pharmacology and toxicology summaries, study tabulations, and the Written Summary of nonclinical pharmacology and toxicology.
- Build, lead, and develop a high-performing Preclinical Development team comprising in vitro pharmacology scientists, in vivo pharmacology scientists, and toxicologists - both internal staff and embedded CRO personnel.
- Set a culture of scientific excellence, objectivity, and regulatory integrity - where data are interpreted accurately regardless of programme pressure and where safety signals are escalated promptly and without bias.
- Mentor and develop team members at all levels; create individual development plans, provide regular performance feedback, and support career progression.
- PhD in pharmacology, toxicology, immunology, cell biology, or a closely related discipline.
- Minimum 15 years of progressive experience in preclinical drug development, with at least 5 years in a senior leadership role with direct accountability for IND-enabling programs.
- Deep expertise in at least two of the three core functions (in vitro pharmacology, in vivo pharmacology, toxicology), with working knowledge of the third.
- Demonstrated experience designing, overseeing, and interpreting GLP toxicology studies (repeat-dose NHP or rodent, safety pharmacology, genotoxicity) in support of IND filing.
- Experience in cell therapy, gene therapy, or advanced therapy development.
- Track record of successful IND submissions with clear accountability for the nonclinical pharmacology and toxicology sections.
- Experience managing CRO relationships for outsourced preclinical and GLP studies, including vendor qualification, protocol development, monitoring, and report review.
- Proven ability to lead, mentor, and build high-performing scientific teams in a fast-paced biotech environment.
Vacancy posted 15 days ago
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