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Principal Scientist, Toxicology - Simply Biotech

TalentZok

San Diego, CA

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JOB DETAILS
SALARY
$160,000–$210,000 Per Year
LOCATION
San Diego, CA
POSTED
19 days ago
Principal Scientist, Toxicology - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
 
Immediate opening for a Principal Scientist, Toxicology in San Diego, CA who possess:
  • Ph.D. in Toxicology, Pharmacology, or a related scientific discipline. 
  • Minimum of 5-7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment. Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions. 
  • Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA
  • DABT Certification is strongly preferred
 
Email resumes to

aencarnacion@simplybiotech.com

and call 858.427.3668.
      
FULL DESCRIPTION: The Principal Toxicologist serves as the primary scientific expert and client-facing lead within our preclinical research group. You will design, oversee, and interpret a broad range of GLP-compliant toxicology studies for pharmaceutical and biotechnology partners. You will also be responsible for leading multiple GLP studies as Study Director, ensuring data integrity, study execution, and scientific interpretation that support regulatory submissions including IND, NDA, and BLA.
 
The right candidate will have demonstrated success in navigating FDA expectations, preparing high-quality nonclinical packages, and contributing directly to regulatory approvals.
   
The selected candidate will be responsible for:   
  • Scientific Strategy and Client Partnership
    1. Serve as the principal scientific contact for clients, building long-term partnerships grounded in trust, transparency, and technical excellence.
    2. Collaborate with clients to understand program objectives, ensuring study designs reflect both regulatory expectations and drug development goals rather than generic service deliverables.
    3. Develop scientifically rigorous and customized toxicology study designs that align with FDA guidance, ICH expectations, and clinical-stage needs.
  • Study Oversight and Execution
    1. Function as Study Director for GLP toxicology studies, with responsibility for scientific conduct, data accuracy, final reporting, and regulatory readiness.
    2. Maintain a strong portfolio of completed studies, demonstrating consistent success from protocol development through final reporting and client delivery.
    3. Lead cross-functional coordination across in vivo and in vitro operations to ensure efficiency, consistency, and GLP compliance.
    4. Monitor study performance proactively to identify risks, troubleshoot issues, and maintain timelines.
  • Data Analysis and Reporting
    1. Integrate toxicology, pathology, and clinical pathology data to generate meaningful, defensible conclusions for regulatory and scientific purposes.
    2. Prepare, review, and sign off on high-quality study reports that accurately reflect study outcomes and support regulatory submissions.
    3. Communicate study findings clearly and confidently in client meetings, regulatory interactions, and technical presentations.
  • Regulatory and Quality Assurance
    1. Ensure all studies are performed in full compliance with FDA GLP regulations and applicable international guidelines (e.g., ICH, OECD, ISO 10993).
    2. Support clients by authoring or contributing to nonclinical sections of IND, NDA, and BLA submissions, leveraging direct experience with FDA expectations.
    3. Represent our Research during audits and health authority inspections, providing scientific and regulatory justification for study decisions and data integrity.
 
  
  The selected candidate will also possess: 
  • Ph.D. in Toxicology, Pharmacology, or a related scientific discipline.
  • Minimum of 5-7 years of experience designing, directing, and interpreting GLP toxicology studies, preferably within a CRO environment.
  • Demonstrated record of serving as Study Director for multiple GLP studies, with completed studies that contributed to successful FDA submissions.
  • Experience preparing or contributing to IND/NDA/BLA nonclinical packages, with familiarity interacting with FDA or supporting sponsor regulatory strategy.
  • Proven ability to distinguish between CRO service execution and the strategic, milestone-driven requirements of drug development.
  • D.A.B.T. certification strongly preferred (or active pursuit/eligibility).
 
 
Salary Range: $160-210k/year  
     
For immediate and confidential consideration, please email your resume to

aencarnacion@simplybiotech.com

and call 858.427.3668.
 
More information can be found at www.simplybiotech.com


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