BioPhase
Principal Scientist, Preclinical Toxicology
Status: FTE
Comp DOE ~180k
Must be DABT certified
Base pay range $160,000.00/yr - $190,000.00/yr
Position Overview A fast-growing preclinical research organization is seeking a seasoned scientific leader to guide its toxicology portfolio. This role centers on shaping nonclinical strategy, directing regulated studies, and serving as a key scientific point of contact for external partners. The Principal Toxicologist will oversee complex GLP programs, safeguard data quality, and help advance investigational therapies toward regulatory milestones.
About the Organization This organization provides contract research support to biotechnology and pharmaceutical clients, specializing in GLP-aligned toxicology and safety evaluations. The team conducts high-quality preclinical studies that contribute directly to major regulatory filings. They emphasize scientific rigor, operational precision, and collaborative engagement to accelerate early-stage drug development.
Role Purpose The Principal Toxicologist functions as the primary scientific expert for nonclinical safety programs. This individual will design studies, direct execution, interpret results, and ensure that all deliverables meet regulatory and scientific expectations. The ideal candidate brings deep experience leading GLP studies and contributing substantively to nonclinical sections of FDA submissions.
Core Responsibilities Scientific Leadership & Client Engagement
Act as the lead scientific liaison for assigned programs, building strong, trust-based relationships with sponsors.
Partner with clients to understand program needs and craft study designs aligned with development strategy and regulatory guidance.
Develop customized toxicology approaches informed by FDA and ICH expectations and specific program objectives.
GLP Study Direction & Operational Oversight
Serve as Study Director with full accountability for protocol design, study conduct, documentation, data accuracy, and final reporting.
Oversee execution across in vivo and in vitro functions, ensuring efficiency, GLP compliance, and scientific rigor.
Monitor study progress, troubleshoot emerging issues, and adjust plans to maintain quality and timelines.
Maintain a strong record of completed studies supporting regulatory progression.
Data Evaluation & Reporting
Synthesize data across toxicology disciplines to form clear, defensible conclusions.
Prepare and/or approve final study reports and provide interpretation suitable for regulatory submissions.
Present findings effectively in sponsor meetings and technical discussions.
Regulatory Alignment & Quality Compliance
Ensure all study activities adhere to applicable GLP requirements and global guidelines (e.g., ICH, OECD, ISO 10993).
Contribute to nonclinical sections of IND, NDA, and BLA submissions.
Support audits and inspections by articulating scientific rationale and ensuring data integrity.
Required Background
Ph.D. in Toxicology, Pharmacology, or related discipline.
At least 5–7 years of experience designing and directing GLP toxicology studies, ideally within a CRO or regulated nonclinical environment.
Demonstrated success serving as Study Director on multiple GLP studies incorporated into FDA submissions.
Experience contributing to nonclinical regulatory filings and supporting sponsor interactions with regulatory bodies.
Strong understanding of the distinct needs of CRO execution versus sponsor-driven development strategy.
DABT certification strongly preferred or actively being pursued.
Technical & Professional Skills
Comprehensive knowledge of GLP standards and nonclinical toxicology practices.
Proven ability to manage complex study programs and maintain cross-functional alignment.
Excellent written and verbal communication skills with a professional, client-focused presence.
Ability to manage multiple projects simultaneously while ensuring quality and compliance.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr
Comp DOE ~180k
Must be DABT certified
Base pay range $160,000.00/yr - $190,000.00/yr
Position Overview A fast-growing preclinical research organization is seeking a seasoned scientific leader to guide its toxicology portfolio. This role centers on shaping nonclinical strategy, directing regulated studies, and serving as a key scientific point of contact for external partners. The Principal Toxicologist will oversee complex GLP programs, safeguard data quality, and help advance investigational therapies toward regulatory milestones.
About the Organization This organization provides contract research support to biotechnology and pharmaceutical clients, specializing in GLP-aligned toxicology and safety evaluations. The team conducts high-quality preclinical studies that contribute directly to major regulatory filings. They emphasize scientific rigor, operational precision, and collaborative engagement to accelerate early-stage drug development.
Role Purpose The Principal Toxicologist functions as the primary scientific expert for nonclinical safety programs. This individual will design studies, direct execution, interpret results, and ensure that all deliverables meet regulatory and scientific expectations. The ideal candidate brings deep experience leading GLP studies and contributing substantively to nonclinical sections of FDA submissions.
Core Responsibilities Scientific Leadership & Client Engagement
Act as the lead scientific liaison for assigned programs, building strong, trust-based relationships with sponsors.
Partner with clients to understand program needs and craft study designs aligned with development strategy and regulatory guidance.
Develop customized toxicology approaches informed by FDA and ICH expectations and specific program objectives.
GLP Study Direction & Operational Oversight
Serve as Study Director with full accountability for protocol design, study conduct, documentation, data accuracy, and final reporting.
Oversee execution across in vivo and in vitro functions, ensuring efficiency, GLP compliance, and scientific rigor.
Monitor study progress, troubleshoot emerging issues, and adjust plans to maintain quality and timelines.
Maintain a strong record of completed studies supporting regulatory progression.
Data Evaluation & Reporting
Synthesize data across toxicology disciplines to form clear, defensible conclusions.
Prepare and/or approve final study reports and provide interpretation suitable for regulatory submissions.
Present findings effectively in sponsor meetings and technical discussions.
Regulatory Alignment & Quality Compliance
Ensure all study activities adhere to applicable GLP requirements and global guidelines (e.g., ICH, OECD, ISO 10993).
Contribute to nonclinical sections of IND, NDA, and BLA submissions.
Support audits and inspections by articulating scientific rationale and ensuring data integrity.
Required Background
Ph.D. in Toxicology, Pharmacology, or related discipline.
At least 5–7 years of experience designing and directing GLP toxicology studies, ideally within a CRO or regulated nonclinical environment.
Demonstrated success serving as Study Director on multiple GLP studies incorporated into FDA submissions.
Experience contributing to nonclinical regulatory filings and supporting sponsor interactions with regulatory bodies.
Strong understanding of the distinct needs of CRO execution versus sponsor-driven development strategy.
DABT certification strongly preferred or actively being pursued.
Technical & Professional Skills
Comprehensive knowledge of GLP standards and nonclinical toxicology practices.
Proven ability to manage complex study programs and maintain cross-functional alignment.
Excellent written and verbal communication skills with a professional, client-focused presence.
Ability to manage multiple projects simultaneously while ensuring quality and compliance.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr