Associate Director/Director of Preclinical Development

Kernal Biologics•Boston, MA

11h•Onsite

About The Position

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.

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)
Comprehensive knowledge of preclinical development in autoimmune diseases, with preferred familiarity with immuno-oncology (e.g., CAR-T).
Expertise in state-of-the-art methods for exploring cancer cell–immune cell interactions and assay development for mechanistic characterization of development candidates.
Proven track record of scientific accomplishments, demonstrated by 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 (including multiplex approaches).
Strong passion for innovative research and a desire to make a clinical impact with mRNA therapeutics.
Experience collaborating with the FDA and other regulatory agencies (e.g., TGA) for preclinical and clinical development of autoimmune disease programs.
Extensive experience authoring key regulatory filings (e.g., IND/HREC submissions) 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.
Willingness to learn, teach, and grow in a fast-paced environment.
Commitment to the company’s ultimate goal of serving patients.

Nice To Haves

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

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.