Associate Director/Director of Preclinical Development

The role

This person will lead preclinical development activities in immunology for mRNA 2.0 therapeutics. They will design and oversee pharmacology, toxicology, and DMPK studies for in vivo CAR-T programs.

What you will do

• Guide company's preclinical immunology efforts for mRNA 2.0 therapeutics.
• Design, execute, oversee, and analyze preclinical pharmacology, toxicology, DMPK studies for in vivo CAR-T programs.
• Work with internal and external cross-functional teams, collaborators, funding agencies, and SAB members.
• Stay up-to-date on scientific literature and patent landscape and prepare technical reports and white papers.
• 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.
• Prepare and present preclinical program updates internally and externally.
• Develop TPPs and periodically revise them.

Required qualifications

• PhD. or M.D./Ph.D. in toxicology, pharmacology, immunology, immuno-oncology, genetics, or a related field.
• 7+ years of Biotech/Pharma experience and 3+ years in managerial roles (5+ years of experience may be considered for the Associate Director role).
• Comprehensive knowledge of preclinical development in autoimmune diseases.
• Expertise in state-of-the-art methods for exploring cancer cell–immune cell interactions and assay development.
• Proven track record of scientific accomplishments via publications, patent applications, and key contributions to Go/No-Go decisions.
• Hands-on experience with multi-parameter flow cytometry, qPCR, and Western blotting.
• Familiarity with single-cell sorting and deep immune profiling.
• Experience collaborating with the FDA and other regulatory agencies for preclinical and clinical development of autoimmune disease programs.
• Extensive experience authoring key regulatory filings and leading meetings with regulatory agencies.
• Ability to maintain professional, productive relationships with internal and external stakeholders.
• Excellent written and verbal communication skills.
• Proven success in managing scientists and associates effectively.

Nice to have

• Familiarity with immuno-oncology (e.g., CAR-T).
• Prior experience with mRNA LNPs and in vivo CAR-T therapies.

Benefits

• Competitive 401(k)
• Highly competitive healthcare coverage (PPO/HMO)
• Free parking, monthly subway pass, or a subsidized commuter rail pass
• Free Bluebike Membership
• Gym Membership Support
• Flexible Spending Account
• Paid parental leave, family caregiver leave, medical leave
• Paid life insurance coverage
• On-site cafeteria
• Competitive vacation and sick days per year

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 based in Boston.