Head of Preclinical Development - Cell & Gene Therapy

Summit Strategic Search; New York (NY); On-site; USD 325,000 - 380,000; Full time

Job summary

Summit Strategic Search is seeking a Head of Preclinical Development for a senior leadership role in New York. You will lead the global preclinical program across in vitro pharmacology, in vivo pharmacology, and toxicology, setting scientific standards and IND strategy while guiding design and interpretation of experiments.

You will manage CROs and internal teams, drive translational science for diverse modalities, and interact with regulators to ensure IND readiness within aggressive timelines.

Qualifications

• PhD in related discipline.
• Significant, progressive experience in preclinical drug development and senior leadership with IND-enabling programs.
• Direct cell therapy / CAR-T development experience.
• Deep expertise in in vitro and in vivo pharmacology.
• Track record of successful IND submissions and regulatory interactions.
• Oncology and/or immunology background.
• Experience building and scaling high-performing scientific teams.

Responsibilities

• Define and execute global preclinical development strategy across the pipeline.
• Set standards for in vitro/in vivo pharmacology and toxicology; guide data interpretation.
• Provide preclinical risk assessments for new candidates and partnerships.
• Lead preclinical science for novel modalities including CAR-T and gene-modified platforms.
• Integrate PK/PD/safety data into clinical development strategy and submissions.
• Own IND component and regulatory interactions; ensure IND-ready programs.

Skills

Preclinical leadership

IND strategy

CAR-T development

In vitro pharmacology

Regulatory interactions

Education

PhD in related discipline

Job description

Summit Strategic Search is seeking a Head of Preclinical Development for a senior leadership role in New York. You will lead the global preclinical program across in vitro pharmacology, in vivo pharmacology, and toxicology, setting scientific standards and IND strategy while guiding design and interpretation of experiments.

You will manage CROs and internal teams, drive translational science for diverse modalities, and interact with regulators to ensure IND readiness within aggressive timelines.