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Head of Preclinical Development-Toxicology

of Preclinical Development and Toxicology with a strong toxicology and immunotoxicity background w/ Experience with pharmacokinetics also desired. Direct experience designing and managing animal toxicology studies and other safety studies, and managing external CROs, as well as other IND enabling activities, including generating reports for FDA submission. Primary responsibilities include all aspects of Preclinical Development including the design, development and direction of toxicology, immunological, pharmacology and pharmacokinetics studies. The successful candidate will be an accomplished preclinical development scientist with biologics experience. Excellent planning, budgeting and project management skills are also needed. Primary Responsibilities: Provides strategic and hands-on management ensuring that toxicology studies are conducted in line with the appropriate regulatory guidelines and standards (FDA, WHO, GLP, and ISO). Oversees and manages protocol preparation for toxicology studies. Ensures that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements. Design and management of nonclinical studies. Initiates and manages contracts in conjunction with finance group, coordinates activities with select Contract Research Organizations (CROs) and academic collaborators for preclinical development in the areas of toxicology, pharmacology, pharmacokinetics. Prepare reports, regulatory documents and INDs. Works closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner. Provides preclinical expertise, and strategy, to multi-functional project teams as the preclinical representative. Requirements: Ph.D. in pharmacology, physiology or related discipline. DABT preferred. Minimum of 7 years of pharmaceutical/biotechnology industry experience. Minimum of 5 years hands-on expertise developing and managing preclinical studies including those performed at external CROs. Mastery of preclinical drug development, strategies, practices and FDA regulations. Experience with biologics and related immunological studies required. Demonstrated proficiency in nonclinical study design and management. Demonstrated results in preclinical development and a track record of successful IND, NDA and BLA filings. Previous experience and success with choosing and managing relations with external contractors, including CROs. Experience interacting with U.S. and European regulatory authorities required. Experience with all phases of clinical development, including pre-IND through Phase IV programs and associated regulatory filings. Excellent writing and language skills along with strong communication and team management skills.  

Salem (Massachusetts), Massachusetts