To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03016

About our client Our client is a rapidly growing pharmaceutical company headquartered in North Carolina that is focused on the development and commercialization of various small molecule and protein-based therapeutics. The company has a world-class CEO, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Senior Director – Toxicology North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Represent the company’s toxicology program during presentations to potential partners 2) Communicate (effectively) the relevance and interpretation of study findings to senior management 3) Represent the company’s toxicology program during discussions with regulatory agencies 4) Interact with the scientific staff throughout the company on general matters pertaining to toxicology 5) Represent a non-clinical drug safety evaluation function on multiple project teams 6) Compose and edit relevant sections of regulatory and scientific documents 7) Provide technical expertise to support Project Team goals and objectives 8) Maintain familiarity with developing and executing non-clinical safety drug development plans for novel therapeutics 9) Be familiar with CRO supervision including negotiation of contracts as well as the reviewing and approval of protocol, study data and study reports 10) Maintain knowledge of support functions involving toxicological concerns in other areas (formulations, drug supply, analytical and bioanalytical work) Requirements 1) Ph. D. in Toxicology with expertise in mechanistic approaches to understanding drug toxicity 2) 10+ years of experience in the pharmaceutical industry or in combination with an academic career 3) Experience in writing and reviewing relevant sections of regulatory submissions 4) Familiarity with regulatory requirements with regard to the toxicology components of IND and CTA submissions 5) Familiarity with designing, executing, monitoring and reporting non-clinical safety studies 6) In-depth knowledge in pharmacology, toxicology and FDA regulations related to pharmaceutical products safety assessment 7) Knowledge of US and ICH guidelines 8) Excellent communication skills (written and verbal) 9) Superb leadership, interpersonal and communication skills 10) Good planning, organizational and decision-making skills