Director of Toxicology

Praxis

Director of Toxicology guiding nonclinical safety strategy for Praxis’s CNS medicines. Leading toxicology studies, regulatory submissions, CRO oversight, and cross-functional development decisions.

Posted 8/19/2026full-timeRemote • 🇺🇸 United StatesLead💰 $220,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in nonclinical safety leadership, regulatory toxicology, and the design and oversight of toxicology studies, ensuring compliance with ICH, FDA, and OECD guidelines. Proven ability to evaluate safety findings and communicate risks effectively across cross-functional teams.

Highest-signal resume keywords

Nonclinical Safety LeadershipRegulatory ToxicologyToxicology Study DesignGood Laboratory PracticesDABT Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Toxicology StrategyStudy Protocol DevelopmentSafety PharmacologyReproductive ToxicologyGenetic ToxicologyCarcinogenicity AssessmentAbuse Potential AssessmentIND-Enabling DevelopmentNDA/MAA DocumentationEmerging Safety Findings Evaluation

Soft Skills

Effective CommunicationLeadershipTeam CollaborationScientific Oversight

Tools & Technologies

CRO ManagementRegulatory Submission ToolsData Analysis Software

Certifications & Qualifications

DABT Certification

Industry Keywords

BiotechnologyPharmaceuticalCROFDAICHOECDGLPNonclinical Safety AssessmentClinical PharmacologyDiscovery

About the role

Key responsibilities & impact

Provide scientific, strategic, and regulatory leadership for nonclinical safety activities across Praxis’s portfolio of small molecule and antisense oligonucleotide therapies for CNS disorders
Own toxicology strategy for designated programs from discovery and candidate selection through IND-enabling development and toward NDA/MAA
Design and oversee discovery, exploratory, investigative, and regulatory toxicology studies, including non-GLP and GLP studies
Lead studies from protocol development through interpretation and final reporting
Evaluate emerging safety findings, assess relevance to human risk, and recommend development paths
Lead regulatory toxicology activities and contribute to INDs, CTAs, IBs, DSURs, NDA/MAA-related documents, and responses to FDA and other global health authorities
Direct CROs, consultants, and external partners, ensuring scientific quality, compliance, timelines, and communication
Partner with Discovery, DMPK, Bioanalytical, Clinical Pharmacology, Regulatory, Clinical, and other functions
Represent Nonclinical Safety Assessment on cross-functional teams and communicate risks and recommendations
As the function grows, potentially lead and develop direct reports

Requirements

What you’ll need

Master's degree or PhD preferred in Toxicology, Pharmacology, Pharmacy, Biology, or a related scientific discipline
DABT certification is desirable
8+ years of relevant biotechnology, pharmaceutical, CRO, regulatory agency, or combined experience
Meaningful responsibility for nonclinical safety programs and significant experience directing or monitoring toxicology studies
Deep expertise in general toxicology and the design, conduct, interpretation, and reporting of nonclinical safety studies
Experience in reproductive toxicology, genetic toxicology, safety pharmacology, carcinogenicity, and/or abuse potential assessment is highly desirable
Strong command of regulatory toxicology
Working knowledge of ICH, FDA, OECD, and other applicable U.S. and international requirements and guidance
Prior experience as an FDA Pharmacology/Toxicology reviewer or comparable experience navigating complex nonclinical interactions with global health authorities is highly valued
In-depth knowledge of Good Laboratory Practices
Ability to provide effective scientific oversight of GLP studies performed by external partners
Experience leading and developing toxicology talent
Comfort with screen work, basic hand coordination, clear communication, and occasional movement

Benefits

Comp & perks

Remote work arrangement
Flexibility and willingness to travel as needed
Reasonable accommodations for individuals with disabilities
Equal employment opportunity and commitment to diversity, equity, and inclusion