Preclinical Development

About Kernal Biologics, Inc. 

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. Based in Boston, the company is backed by Hummingbird Ventures, Amgen, Lilly, HBM, ARPA-H, and NVIDIA. Kernal Bio is transforming the future of cell therapy design and delivery.

Job Summary:

Kernal Bio is seeking an experienced leader with deep expertise in immunology to lead our mRNA therapeutics efforts. This person will report to the Senior Vice President of R&D and will be responsible for leading preclinical development activities in immunology. In addition, this person will work closely with computational biology and mRNA delivery leadership to execute on company goals. The successful candidate must be able to work in a fast-paced and highly dynamic start-up environment. Ideal candidate will be an inspirational leader and a great team player with a proven track record in drug development, excellent communication skills, and effective management style.

Responsibilities:

• Guide company’s preclinical immunology efforts for mRNA 2.0 therapeutics.
• Independently design, execute, oversee, and analyze preclinical pharmacology, toxicology, DMPK studies for in vivo CAR-T programs.
• Work collaboratively with internal and external cross-functional teams, collaborators, funding agencies, and SAB members to align, plan and execute on the overall research and development plans
• 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 in response to internal data generation and ongoing landscape analysis.

Requirements:

• PhD. or M.D./Ph.D. in toxicology, pharmacology, immunology, immuno-oncology, genetics, or a related field, with 7+ years of Biotech/Pharma experience and 3+ years in managerial roles. (Candidates with 5+ years of experience may be considered for the Associate Director role)