$135,000–$150,000 Per Year
Analysis Skills, Biology, Biotech and Pharmaceutical, Budgeting, Business Development, Cardiovascular, Cell Cultures, Clinical Trial, Contract Research Organization (CRO), Customer Support/Service, Documentation, Drug Development, Drug Discovery, FDA (Food and Drug Administration), Flexible Spending Accounts, GLP (Good Laboratory Practices), Gene Therapy, Healthcare, Hemophilia, Investigational New Drug (IND), Leadership, Maintain Compliance, Manufacturing, Mentoring, Metabolic Disorders, Oncology, Operational Strategy, People Management, Pharmacology, Pre-Clinical Development, Pre-Clinical Trials, Project/Program Management, Proposal Development, Quality Assurance, Quality Control, Quality Metrics, Regulations, Regulatory Compliance, Research & Development (R&D), Research Protocols, Safety/Work Safety, Small Molecules, Team Player, Technical Leadership, Toxicology, Toxicology Research, Veterinary Medicine
Position: Principal Scientist, Specialty Toxicology
Salary Range: $135k - $150k (DOE)
Location: Carlsbad, CA (on-site)
About Pharmaron
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.
Job Overview:
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
Key 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
What We're Looking For:
- Ph.D. in Toxicology, Pharmacology, or a related field.
- Board certification in toxicology (e.g., DABT) highly desired.
- 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.
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
- 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
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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