Role Overview
Vice President, Head of Preclinical Development (Early Drug Development), Somerset, NJ.
Key Responsibilities
- Define and execute the preclinical development strategy globally from candidate nomination through IND-enabling studies.
- Serve as internal scientific authority for in vitro pharmacology, in vivo pharmacology, and toxicology (methodological standards, experimental design, data interpretation).
- Lead preclinical science for novel modalities (lentiviral vector-based in vivo CAR-T, ex vivo cell therapies, gene-modified immune cell platforms).
- Integrate PK/PD, safety, biodistribution and related data into compound narratives supporting clinical strategy, dose selection, and regulatory submissions.
- Provide rigorous preclinical risk assessments for new candidates and partnership/lifecycle management opportunities.
- Own IND nonclinical content: integrated pharmacology/toxicology summaries, study tabulations, and Written Summary of nonclinical pharmacology and toxicology.
- Build and lead a high-performing preclinical team (internal scientists and embedded CRO personnel).
- Set culture of scientific excellence, objectivity, and regulatory integrity; escalate safety signals promptly.
- Mentor and develop team members.
Requirements
- PhD in pharmacology, toxicology, immunology, cell biology, or related field.
- 15+ years preclinical drug development experience; 5+ years senior leadership with IND-enabling accountability.
- Deep expertise in at least two of: in vitro pharmacology, in vivo pharmacology, toxicology.
- GLP toxicology experience (repeat-dose NHP/rodent, safety pharmacology, genotoxicity) supporting IND.
- Experience in cell/gene/advanced therapy development.
- Track record of IND submissions; CRO management for outsourced preclinical/GLP work.
Benefits (selected)
- Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; paid time off; base pay range listed; other voluntary insurance and benefits.