Senior Toxicologist - Clinical Research and Medical Affairs

Kelly Scientific Resources is currently recruiting for a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The current opening is for a Senior Toxicologist that will be the spokesperson for the toxicology program and report to the Senior Vice President of Clinical Research and Medical Affairs. The ideal candidate will have demonstrated leadership, interpersonal, and communication skills as well as strong planning, organization, and decision-making capabilities. This is a unique opportunity to join a successful company during a period of exceptional growth.Specifically, this individual will:' Represent the Company's toxicology program during presentations to potential partners' Represent the Company's toxicology program during discussions with regulatory agencies' Effectively communicate the relevance and interpretation of study findings to senior management ' Represent a non-clinical drug safety evaluation function on multiple project teams' Interact with the scientific staff throughout the company on general matters pertaining to toxicology' Compose and edit relevant sections of regulatory and scientific documents' Provide technical expertise to support project team goals and objectives' Be familiar with development and execution of non-clinical safety drug development plans for novel therapeutics ' Be familiar with support functions involving toxicological concerns in other areas including formulations, drug supply, analytical, and bioanalytical work' Be familiar with CRO oversight, including negotiation of contracts, and the review and approval of protocol, study data, and study reportsMinimum job requirements include:' A PhD in toxicology with expertise in mechanistic approaches to understanding drug toxicity' 10+ years of experience in the pharmaceutical industry or in combination with an academic career' Familiarity with regulatory requirements with regard to the toxicology components of IND and CTA submissions' Familiarity with designing, executing, monitoring, and reporting nonclinical safety studies' Experience in writing and reviewing relevant sections of regulatory submissions' Excellent written and verbal communication skills' In-depth knowledge in pharmacology, toxicology, and FDA regulations related to pharmaceutical products safety assessment, including thorough knowledge of US and ICH guidelinesThis opportunity provides a generous compensation package and relocation assistance. Learn more about company