Principal Scientist, Specialty Toxicology

Pharmaron • Carlsbad, CA

6d • Onsite

About The Position

The Principal Scientist, Specialty Toxicology, will play an integral role in expanding operations and the customer base by leading and managing preclinical studies, with a primary focus on toxicology, pharmacology, and biodistribution for cell & gene therapy programs. Some specialty areas will include central nervous system (CNS), oncology (CAR-T), hemophilia, cardiovascular, metabolic disorders, and others This position ensures the safety of products and substances and provides expert toxicological guidance to clients.
The role will serve as the primary SME for cell and gene therapy (CGT) and toxicology preclinical programs, with responsibility for scientific leadership, regulatory‑ready execution, and client engagement for large or complex studies. This individual will provide strategic and operational oversight across in vivo toxicology, CGT, cell culture, flow cytometry (FACS), and formulations, and will play a key role in the growth and maturation of the department

Requirements

• Ph.D. in Toxicology, Pharmacology, or a related field.
• Experience with GLP (Good Laboratory Practice) and non-GLP toxicology
• A minimum of 5 years of experience in preclinical studies, with a strong track record in designing and overseeing toxicology studies.
• Demonstrated experience supporting IND-enabling nonclinical studies for FDA IND submissions for cell and/or gene therapy products
• Prior experience serving as Study Director for toxicology and/or CGT programs in a CRO or pharmaceutical/biotech environment.
• Knowledge and experience in cell and gene therapy
• Previous experience in a CRO or pharmaceutical/biotechnology
• Strong work ethic, self-motivation, and ability to adapt in a dynamic team environment.

Nice To Haves

• Board certification in toxicology (e.g., DABT) highly desired.

Responsibilities

• Serve as primary and lead Study Director for complex or high‑profile cell and gene therapy and toxicology programs.
• Lead the design, planning, and execution of preclinical toxicology studies, including selection of appropriate animal models, dose strategies, and study endpoints.
• Provide scientific and technical leadership across CGT, toxicology, cell culture, flow cytometry (FACS), and formulations activities.
• Analyze and interpret study data, draw scientifically defensible conclusions, and make clear recommendations aligned with client and regulatory expectations.
• Develop and approve study protocols, timelines, budgets, and amendments in collaboration with Project Management and operations teams.
• Monitor study progress to ensure adherence to approved protocols, GLP/non‑GLP requirements, and internal quality standards.
• Proactively identify, assess, and resolve study deviations, technical challenges, or operational risks.
• Ensure studies are conducted in compliance with applicable regulatory guidelines (e.g., FDA, OECD, GLP as applicable).
• Prepare, review, and sign comprehensive study reports suitable for IND‑enabling and regulatory submissions.
• Support client IND strategies through generation of high‑quality, regulatory‑ready study data and documentation.
• Maintain current knowledge of evolving CGT and toxicology regulatory and scientific guidance.
• Participate in leadership and mentorship to more junior Study Directors, in vivo scientists, cell culture/FACS scientists, and other technical staff.
• Provide input on optimization, diversification, and expansion of service offerings, including new CGT‑related capabilities.
• Act as a key scientific contact for clients, supporting study design discussions, results interpretation, and program strategy.
• Interface effectively with in vivo operations, QA/QC, veterinary staff, Project Management, and Business Development.
• Support proposal development with technical contributions to client discussions

Benefits

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree