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Associate Director/Director of Toxicology EnVivo Pharmaceuticals
The Associate Director/Director of Toxicology will have overall responsibility for the design, conduct and reporting of Toxicology studies in support of EnVivo?s development programs. Working with Research and Development colleagues, the Associate Director/Director of Toxicology will develop Toxicology strategies consistent with Regulatory requirements and individual program objectives, and oversee the design, conduct and reporting of the individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, review and approval of study protocols, monitoring of in-study activities, and review and reporting of interim and final study results and approval of study reports. The individual will serve on Development teams and regularly interface with colleagues to ensure timely and accurate dissemination of study findings. The individual will also be responsible for authoring and/or review of Safety Pharmacology and Toxicology sections of all regulatory documents, including IND, CTA, IB, annual reports, and NDA/MAA submissions. This individual will be responsible for all issues related to toxicology at EnVivo. Minimum Requirements:
? Must possess a PhD in Toxicology, or equivalent; DABT certification is desirable
? Significant (8-15 years) industry experience in conduct and/or oversight of small molecule Toxicology programs
? Extensive experience managing programs with external CROs and consultants
? Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Toxicology sections of Regulatory submissions for IND- and NDA-stage projects
? Demonstrated ability to independently design Safety Pharmacology/Toxicology studies to characterize the safety profile of clinical development compounds
? Experience working in a cross functional team and matrix environment
? Strong written, presentation and verbal communication skills
| Location: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
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EnVivo Pharmaceuticals
Investors: BCM Technologies, Fidelity BiosciencesAll Jobs: at EnVivo Pharmaceuticals
| Web Site: | www.envivopharma.com |
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| Headquarters: | 480 Arsenal Street Building 1 Watertown, MA 02472 United States |
| Industry: | Biotechnology |
