Director of Toxicology

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide scientific, strategic, and regulatory leadership for nonclinical safety initiatives across Praxis’s portfolio of small molecule and antisense oligonucleotide therapies targeting CNS disorders.

• Take ownership of toxicology strategies for assigned programs from discovery and candidate selection through IND-enabling development and towards NDA/MAA.

• Design and supervise discovery, exploratory, investigative, and regulatory toxicology studies, encompassing both non-GLP and GLP studies.

• Lead studies from protocol creation through to interpretation and final reporting.

• Assess emerging safety findings, evaluate their relevance to human risk, and recommend developmental pathways.

• Oversee regulatory toxicology efforts and contribute to INDs, CTAs, IBs, DSURs, documentation related to NDA/MAA, and responses to the FDA and other global health authorities.

• Manage CROs, consultants, and external partners, ensuring scientific quality, compliance, timelines, and effective communication.

• Collaborate with Discovery, DMPK, Bioanalytical, Clinical Pharmacology, Regulatory, Clinical, and other departments.

• Represent Nonclinical Safety Assessment in cross-functional teams and communicate risks and recommendations effectively.

• As the function expands, potentially lead and develop direct reports.

⛳️ Requirements

• A Master's degree or PhD is preferred in Toxicology, Pharmacology, Pharmacy, Biology, or a related scientific field.

• DABT certification is advantageous.

• Over 8 years of relevant experience in biotechnology, pharmaceuticals, CROs, regulatory agencies, or a combination thereof.

• Significant responsibility for nonclinical safety programs and extensive experience in directing or monitoring toxicology studies.

• Comprehensive expertise in general toxicology along with the design, execution, interpretation, and reporting of nonclinical safety studies.

• Experience with reproductive toxicology, genetic toxicology, safety pharmacology, carcinogenicity, and/or abuse potential assessment is highly desirable.

• Strong understanding of regulatory toxicology.

• Familiarity with ICH, FDA, OECD, and other relevant U.S. and international guidelines and requirements.

• Prior experience as an FDA Pharmacology/Toxicology reviewer or similar experience in navigating complex nonclinical interactions with global health authorities is highly regarded.

• In-depth knowledge of Good Laboratory Practices.

• Capability to provide effective scientific oversight of GLP studies conducted by external partners.

• Experience in leading and developing toxicology talent.

• Comfort with screen work, basic hand coordination, clear communication, and occasional mobility.

🏝️ Benefits

• Remote work arrangement.

• Flexibility and willingness to travel as required.

• Reasonable accommodations for individuals with disabilities.

• Commitment to equal employment opportunity, diversity, equity, and inclusion.