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Director Preclinical Development Jobs (NOW HIRING)

Legend Biotech USA, Inc.

Minimum 15 years of progressive experience in preclinical drug development, with at least 5 years in a senior leadership role with direct accountability for IND-enabling programs.Deep expertise in at ...

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How much do director preclinical development jobs pay per year?

As of Sep 12, 2026, the average yearly pay for director preclinical development in the United States is $92,386.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,000.00 and $108,500.00 per year, depending on experience, location, and employer.

What is a director preclinical development?

A Director of Preclinical Development oversees the early-stage research and testing of drug candidates before they enter clinical trials. They manage preclinical studies, ensuring regulatory compliance, safety, and efficacy assessments. This role involves coordinating with cross-functional teams, external partners, and regulatory agencies to advance promising compounds. Strong expertise in toxicology, pharmacology, and regulatory guidelines is essential. The director plays a key role in shaping the preclinical strategy to support successful drug development.

What are the typical responsibilities and team dynamics for a director preclinical development?

A Director of Preclinical Development is responsible for overseeing the planning, execution, and management of preclinical research programs, ensuring that studies meet scientific, regulatory, and project milestones. You will typically work with cross-functional teams including toxicologists, pharmacologists, regulatory affairs professionals, and external partners, fostering collaboration throughout the drug development process. The role often involves reviewing study designs and data, preparing regulatory submissions, and providing strategic direction to advance compounds toward clinical testing. Working closely with upper management, you'll play a key part in shaping research priorities and resource allocation. This position offers significant influence over drug development strategies and opportunities for advancement to higher executive or scientific leadership roles.

What are the key skills and qualifications needed to thrive in the director preclinical development position, and why are they important?

To thrive as a Director Preclinical Development, you need deep expertise in pharmaceutical or biotechnology research, strong project management abilities, and an advanced degree (Ph.D., Pharm.D., or equivalent) in a life sciences field. Familiarity with regulatory guidelines (such as GLP), experience using data management and statistical analysis software, and prior leadership roles in preclinical studies are essential. Exceptional communication, problem-solving, and team leadership skills set candidates apart in managing multidisciplinary teams and collaborative projects. These competencies are crucial for successfully guiding drug candidates through preclinical stages while ensuring regulatory compliance and timely project delivery.

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Director Preclinical Development jobs near you
Infographic showing various Director Preclinical Development job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 81% Full Time, 15% Part Time, and 2% Contract. Highlights an 85% Physical, 3% Hybrid, and 12% Remote job distribution, with an average salary of $92,386 per year, or $44.4 per hour.

Associate Director/Director of Preclinical Development

Boston, MA • On-site

Kernal Biologics, Inc.
Biotechnology Research and Development • 11 - 50 employees
Learn more about Kernal Biologics, Inc.external

Full-time

Medical, Life, Retirement

Re-posted 17 days ago

Job description

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)
  • 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.
  • Preferred: 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 

Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices for the race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

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