VP, Global Preclinical Development Leader — Cell Therapy

Initial Therapeutics, Inc.; New Jersey; On-site; USD 294,483 - 386,511; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan with company‑匹

Paid parental leave

Job summary

Legend Biotech, based in New Jersey, seeks a visionary VP, Head of Preclinical Development to lead the full preclinical program across in vitro, in vivo pharmacology and toxicology for all pipeline compounds globally. You will build and guide a high‑performing team, set scientific standards, and act as the external face for preclinical science.

You will own IND‑enabling strategies, collaborate with regulatory and partnerships teams, and drive high‑quality, timely submissions while maintaining

Qualifications

• 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.

Responsibilities

• Define and execute the preclinical development strategy across all pipeline programs 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 and data interpretation frameworks.
• Lead preclinical science for modalities including lentiviral vector‑based in vivo CAR‑T, ex vivo cell therapies, and gene‑modified immune cell platforms.
• Integrate preclinical datasets (PK, PD, safety, biodistribution) into coherent narratives informing clinical strategy and regulatory submissions.
• Contribute to portfolio decisions by providing rigorous preclinical risk assessments for new candidates and partnership assets.
• Own the preclinical component of IND applications, including integrated pharmacology and toxicology summaries.
• Build and develop a high‑performing Preclinical Development team including internal staff and embedded CROs.
• Set a culture of scientific excellence and regulatory integrity with unbiased data interpretation.
• Mentor and develop team members; create development plans and support career progression.

Skills

In vitro pharmacology

In vivo pharmacology

Toxicology

Education

PhD in pharmacology/toxicology/immunology

Job description

Legend Biotech, based in New Jersey, seeks a visionary VP, Head of Preclinical Development to lead the full preclinical program across in vitro, in vivo pharmacology and toxicology for all pipeline compounds globally. You will build and guide a high‑performing team, set scientific standards, and act as the external face for preclinical science.

You will own IND‑enabling strategies, collaborate with regulatory and partnerships teams, and drive high‑quality, timely submissions while maintaining