Director of Toxicology

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $220k - $240k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

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👻 Ghost score 19%

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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

• 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