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Preclinical Development information

What is preclinical development?

A Preclinical Development job involves overseeing the research and testing of drug candidates before they enter clinical trials. Professionals in this role design and conduct studies to assess a drug’s safety, efficacy, and pharmacokinetics using laboratory and animal models. They collaborate with scientists, regulatory experts, and project managers to generate data required for regulatory approval. Their work helps identify potential risks and optimize drug formulations before human testing begins.

What are the typical responsibilities of someone working in preclinical development?

Professionals in Preclinical Development are responsible for designing, conducting, and analyzing laboratory and animal studies to evaluate the safety and efficacy of new drug candidates before clinical trials. They often collaborate closely with research scientists, regulatory teams, and project managers to ensure studies meet compliance standards and scientific objectives. Daily tasks may include developing protocols, interpreting data, preparing regulatory documentation, and troubleshooting experimental issues. This role offers opportunities to gain broad exposure to the drug discovery process and can lead to advancement into project leadership or regulatory affairs positions.

What are the key skills and qualifications needed to thrive in preclinical development, and why are they important?

To excel in Preclinical Development, you need a solid background in biology, pharmacology, or related life science fields, often supported by an advanced degree and experience with laboratory research. Familiarity with Good Laboratory Practice (GLP) regulations, data analysis software, and animal study management systems is expected. Strong attention to detail, effective problem-solving skills, and the ability to communicate complex findings clearly are valuable soft skills. These competencies are essential to ensure the successful and compliant progression of drug candidates toward clinical trials.

What are the most commonly searched types of Preclinical Development jobs in New York?

The most popular types of Preclinical Development jobs in New York are:

What are popular job titles related to Preclinical Development jobs in New York?

For Preclinical Development jobs in New York, the most frequently searched job titles are:

What job categories do people searching Preclinical Development jobs in New York look for?

The top searched job categories for Preclinical Development jobs in New York are:

Preclinical Development jobs near you
Infographic showing various Preclinical Development job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

VP, Head of Preclinical Development

Legend Biotech US

Somerset, NJ • Hybrid

Full-time

Re-posted 15 days ago

Job description

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.

Requirements

  • 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.

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