Company:  Confidential

Job Title: Director of Toxicology

Job Number: 65891

Location: Remote, US

Job Description

In this newly created role, you will be responsible for the design and oversight of nonclinical toxicology and safety pharmacology studies conducted at Contract Research Organizations (CROs). As a key member of the regulatory affairs and toxicology team, you will support drug development programs from the preclinical candidate selection stage through market application in consultation with cross-functional team members and niche expert consultants as needed. The position reports to and will work closely with the SVP of Regulatory Affairs & Toxicology.


* Conduct preliminary risk assessment of drug candidates, including characterization of known and theoretical target-related liabilities based on literature and regulatory summaries * Design nonclinical safety assessment strategies and establish project timelines and budgets to support programs from the pre-IND stage through market application * Establish and maintain contracts and external relationships with CROs and consultants * Collaborate with a multi-disciplinary team to optimize toxicology planning and execution with respect to species selection, drug supply requirements, and study duration/dose regimen  * Work closely with cross-functional team members to ensure nonclinical studies are performed in a timely fashion and with the highest scientific standards * Design, execute, and monitor nonclinical safety studies at CROs (single/repeat dose toxicity of appropriate duration, DART, and specialty studies as needed) in accordance with applicable standards (e.g., FDA, ICH, WHO, and GLP) * Author nonclinical sections of clinical and regulatory documents * Regularly report the progress of projects and interpretation of results in a timely and concise manner to project teams and senior management * Keep up to date with pertinent literature, regulatory guidances, and regulations

Required Skills

* PhD in Pharmacology, Toxicology, or related discipline * Minimum of 8 years of industry experience as a toxicologist (level will commiserate with years of experience) * Comprehensive understanding of drug development, including safety assessment models and FDA/ICH guidances * Hands-on experience in nonclinical development and a track record of contributions to regulatory filings. Experience with biologics is preferred but not required * Excellent oral communication skills to clearly explain complex issues and progress reports to a variety of audiences across functions and across levels at both internal and external meetings * Excellent written communication skills for authorship of nonclinical sections of regulatory documents OTHER REQUIREMENTS Ability and willingness to travel (US) up to 25%

Application Deadline: 2023-10-20


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