Praxis Precision Medicines
Director of Toxicology
RemoteUnited States only
- Role
- Research
- Experience
- Lead
$220k–$240k/yr
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No BS summary
Senior toxicology lead for a US-based clinical-stage biopharma; owns nonclinical safety strategy for CNS small-molecule and ASO therapies from discovery to IND/NDA. Needs 8+ years of nonclinical safety experience and deep regulatory toxicology expertise (ICH, FDA, OECD, GLP). Master's/PhD preferred, DABT desirable; US-remote with travel.
Core skills
Regulatory toxicology
Optional skills
Reproductive toxicologyGenetic toxicologySafety pharmacologyDABT certification
What you'll do
- Own nonclinical safety strategy for assigned programs (candidate selection through IND and NDA/MMA milestones)
- Oversee discovery, exploratory, investigative, and regulatory (non-GLP/GLP) toxicology studies from protocol to final report
- Evaluate emerging safety findings, their relevance to human risk, and pragmatic follow-ups
- Contribute to INDs, CTAs, IbsIbs, DSURs, NDA/MAA documents and global health authority responses
- Direct CROs, consultants, and external partners for scientific quality, compliance, and timelines
- Partner with Discovery, reactive DMPK, Bioanalytical, Clinical Pharmacology, Regulatory, Clinical teams
- Represent Nonclinical Safety Assessment on cross-functional teams
What they require
- Faculty such as Master's degree or PhD in Toxicology, Pharmacology, Pharmacy, Biology, or related discipline (preferred)
- 8+ years of relevant biotechnology, pharmaceutical, CRO or regulatory-agency experience with nonclinical-safety responsibility for nonclinical safety programs
- Deep expertise in general toxicology and design/conduct/interpretation/reporting of nonclinical safety studies
- Strong command of regulatory toxicology toward working knowledge of relevant ICH, FDA, OECD and international guidance
- In-depth knowledge of Good Laboratory Practices and oversight of GLP studies with external partners
- Experience leading and developing toxicology talent (setting priorities, scientific coaching, fostering accountability and learning)
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.
$220k–$240k/yr