Director, Toxicology & Nonclinical Safety (Remote)

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 220,000 - 240,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking a Director of Toxicology to provide scientific, strategic, and regulatory leadership for nonclinical safety across our CNS programs.

You will own the toxicology strategy from discovery through IND-enabling development and contribute to NDA/MAA preparations, with hands-on leadership and clear risk communication. You will lead GLP and non-GLP studies, oversee CROs, and partner with DMPK, Regulatory, Clinical, and Discovery teams to translate safety data

Qualifications

• Master's degree or PhD in Toxicology or related field; DABT desirable.
• 8+ years in biotech/pharma with responsibility for nonclinical safety programs.
• Experience directing or monitoring toxicology studies and GLP
• Strong regulatory toxicology knowledge (ICH, FDA, OECD).

Responsibilities

• Own nonclinical safety strategy for assigned programs and milestones.
• Design and oversee non-GLP and GLP toxicology studies.
• Evaluate emerging safety findings and advise development teams.
• Lead regulatory toxicology activities including INDs/NDA/MAA related work.
• Direct CROs and external partners with accountability for quality and timelines.
• Partner across Discovery, DMPK, Regulatory, Clinical, and other teams.
• Represent Nonclinical Safety on cross-functional teams and communicate risks.

Skills

Nonclinical toxicology leadership

Regulatory strategy & FDA interactions

Cross-functional leadership

GLP oversight

Education

Master's or PhD in Toxicology/Pharmacology/Biology or related field

Tools

DABT certification

ICH/FDA regulatory knowledge

Job description

Praxis Precision Medicines, Inc. is seeking a Director of Toxicology to provide scientific, strategic, and regulatory leadership for nonclinical safety across our CNS programs.

You will own the toxicology strategy from discovery through IND-enabling development and contribute to NDA/MAA preparations, with hands-on leadership and clear risk communication. You will lead GLP and non-GLP studies, oversee CROs, and partner with DMPK, Regulatory, Clinical, and Discovery teams to translate safety data