Vice President, Preclinical Development Cell and Gene Therapy

Lead the preclinical science that carries a next-generation cell and gene therapy pipeline from candidate nomination to first-in-human.

Our client is a clinical-stage, global biotechnology company developing cell and gene therapies for hematological malignancies, solid tumors, and autoimmune disease. With a global research and development footprint and a rapidly advancing pipeline — including next-generation in vivo cell therapy programs — the organization is scaling its Early Drug Development function and is seeking a Head of Preclinical Development to build and lead its global preclinical organization.

This is a senior, externally visible scientific leadership role accountable for the full preclinical development program — in vitro pharmacology, in vivo pharmacology, and toxicology — across every pipeline compound, globally. It is a strategy-and-execution leadership seat, not a hands-off oversight role: the successful leader will set the organization's scientific standards and own IND strategy while staying close enough to the science to guide experimental design and data interpretation directly.

This person serves as the internal scientific authority and the external face for preclinical science across regulatory, partnership, and publication contexts, and plays a critical role in transitioning assets from research into the clinic.

This list represents the major duties of the role and is not all-inclusive. The successful candidate may be asked to perform related duties beyond those described here.

• Define and execute the global preclinical development strategy across the entire pipeline, 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.
• Contribute to portfolio decisions by providing rigorous preclinical risk assessments for new candidates, partnership assets, and lifecycle-management opportunities.
• Play a critical role in advancing assets from research into clinical development.

• Lead preclinical science for novel modalities, including viral-vector–based in vivo CAR-T, ex vivo cell therapies, and gene-modified immune cell platforms, with a deep understanding of the distinct preclinical characterization requirements of each.
• Integrate preclinical datasets (PK, PD, safety, biodistribution) into coherent compound narratives that inform clinical development strategy and regulatory submissions.
• Drive dose selection and support clinical study design.

• 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.
• Lead regulatory interactions with the FDA and global health authorities across modalities.
• Ensure programs are IND-ready and aligned with clinical development goals under aggressive timelines, without compromising scientific rigor.

• Select, qualify, and oversee CRO partners for outsourced preclinical and GLP studies, including protocol development, study monitoring, and report review.
• Manage external research partnerships and embedded CRO personnel as an extension of the internal team.
• Build, lead, and develop a high-performing, integrated preclinical team spanning in vitro pharmacology, in vivo pharmacology, and toxicology across multiple global sites.
• Set a culture of scientific excellence, objectivity, and regulatory integrity — where data are interpreted accurately…