VP, Preclinical Development Leader – IND Programs

BioSpace; New Jersey; Presencial; USD 294.000 - 387.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

401(k) retirement with company match

Paid parental leave

Excellent PTO policy and holidays

Descripción de la vacante

Legend Biotech USA seeks a VP, Head of Preclinical Development to lead a global preclinical program across in vitro and in vivo pharmacology and toxicology. This senior role drives IND‑enabling studies, data interpretation standards, and interactions with regulatory partners.

You will build and mentor a multidisciplinary team, ensuring scientific excellence and compliant, rigorous submissions for novel cell and gene therapies.

Formación

• PhD in pharmacology, toxicology, immunology, cell biology, or closely related field.
• Minimum 15 years of progressive preclinical drug development experience with 5+ years in a senior leadership role for IND enabling programs.
• Deep expertise in at least two core functions (in vitro pharmacology, in vivo pharmacology, toxicology).
• Experience designing, overseeing GLP toxicology studies in support of IND filings.
• Experience in cell therapy, gene therapy, or advanced therapy development.
• Track record of successful IND submissions with nonclinical sections.

Responsabilidades

• Define and execute the preclinical development strategy globally from candidate nomination through IND‑enabling studies.
• Serve as internal scientific authority on in vitro/in vivo pharmacology and toxicology — set standards and data interpretation frameworks.
• Lead preclinical science for modalities including lentiviral vector‑based in vivo CAR‑T and ex vivo cell therapies.
• Integrate preclinical data into coherent narratives informing clinical development strategy and dose selection.
• Contribute to portfolio decisions by providing preclinical risk assessments for new candidates and partnerships.
• Own the preclinical component of IND applications and deliver summaries, study tabulations, and Written Summaries.
• Build and lead a high‑performing Preclinical Development team with internal and CRO staff.
• Foster a culture of scientific excellence and regulatory integrity, ensuring unbiased data interpretation.
• Mentor team members and support career progression with development plans and feedback.

Conocimientos

IND-enabling

GLP toxicology

In vivo pharmacology

In vitro pharmacology

CRO management

Team leadership

Cell therapy

Gene therapy

Educación

PhD in pharmacology/toxicology/immunology/cell biology

Descripción del empleo

Legend Biotech USA seeks a VP, Head of Preclinical Development to lead a global preclinical program across in vitro and in vivo pharmacology and toxicology. This senior role drives IND‑enabling studies, data interpretation standards, and interactions with regulatory partners.

You will build and mentor a multidisciplinary team, ensuring scientific excellence and compliant, rigorous submissions for novel cell and gene therapies.