Director of Toxicology

Vaga não está no LinkedIn

🕒 Agosto 19

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $220.000 - $240.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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