Principal Scientist, Toxicology

The successful candidate will have a key role in developing regulatory toxicology strategies and providing deep scientific interpretation of nonclinical findings as to their relevance and translation into clinical and regulatory development. The role will involve overseeing the conduct of non-GLP screening toxicity studies and managing externallyconducted GLP toxicology studies to support development of multiple drug candidates in Alnylam's industry-leading RNAi Therapeutics pipeline. Collaborate with Research to inform on in vivo study design and interpretation as part of lead candidate selection Collaborate with medicinal chemists and analytical scientists to ensure synthesis, formulation, and delivery of test articles for use in toxicology studies. Collaborate with DMPK and bioanalytical scientists to design and integrate DMPK results from studies on all assigned research and drug development programs. Use available published literature and other relevant sources to author target safety assessments for new therapeutic targets Represent Toxicology and Early Development on project teams, guiding development programs and project prioritization by responding quickly to data from ongoing studies and providing input to management and development teams. Prepare and review toxicology sections of regulatory documents, including preIND packages, INDs, clinical trial applications (CTAs), Investigator Brochures, special protocol reviews, regulatory Briefing Documents and NDAs/MAAs. Summarize experimental results for presentations both within and outside of the company, particularly representing the findings to regulatory authorities. Ph.D. with postdoctoral experience in toxicology or a related field with 5-7+ years relevant experience in the biotechnology/pharmaceutical industry. DABT preferred for the toxicologist. The candidate should have an understanding of the biology associated with RNAi and its application for therapeutic intervention across multiple disease indications Previous experience in managing nonclinical toxicology/safety programs, and design, execution, and regulatory reporting of GLP toxicology and safety pharmacology studies is required. Experience in drug development and regulatory submissions, including IND/CTA and NDA is desired. A proven track record of successful regulatory submissions will enhance candidate consideration. Individual needs to be open-minded, self-motivated, attentive to detail, capable of identifying and solving problems independently, and dedicated to quality and safety of therapeutics. Given that the successful candidate will have leadership responsibilities for representing drug safety evaluation on the relevant multi-functional program teams, he/she will have the ability to independently set and convey the toxicology and non-clinical strategy to colleagues across the R&D matrix. He/she should be an outstanding communicator and presenter in order to communicate our progress to key internal and external audiences. Consistent with the strong scientific basis for all aspects of our work, he/she should enjoy a fast-paced, data-driven environment working in a matrix with various colleagues from R&D to help establish the road map for the discovery and development of RNAi therapeutics.