Associate Director/Director of Preclinical Development

About the Company

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. The company is advancing precision treatments for autoimmune diseases and blood cancers through in vivo CAR-T therapies.

Responsibilities

• Guide company’s preclinical immunology efforts for mRNA 2.0 therapeutics
• Design, execute, oversee, and analyze preclinical pharmacology, toxicology, and DMPK studies for in vivo CAR-T programs
• Work collaboratively with internal and external cross-functional teams, collaborators, and SAB members
• Lead regulatory filings with agencies including FDA, EMA, and TGA
• Manage CROs and collaborate with academic/industry partners for external preclinical studies
• Plan and oversee timelines, budgets, and risk mitigation for preclinical programs
• Develop and periodically revise TPPs based on internal data and landscape analysis

Requirements

• PhD or MD/PhD in toxicology, pharmacology, immunology, immuno-oncology, genetics, or related field
• 7+ years of Biotech/Pharma experience with 3+ years in managerial roles (5+ years considered for Associate Director)
• Comprehensive knowledge of preclinical development in autoimmune diseases
• Expertise in cancer cell–immune cell interactions and assay development
• Hands-on experience with multi-parameter flow cytometry, qPCR, and Western blotting
• Familiarity with single-cell sorting and deep immune profiling
• Experience authoring key regulatory filings (e.g., IND/HREC submissions) and collaborating with the FDA
• Proven success in managing scientists and associates

Preferred Qualifications

• Prior experience with mRNA LNPs and in vivo CAR-T therapies