VP, Head of Preclinical Development

Key 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, 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.