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Job #03057

About our client Our client is a biopharmaceutical company based in Kansas City. They focus on developing novel, first-in-class pharmaceuticals to attend to the medical needs of patients with renal and vascular diseases. The company boasts an exceptional understanding of tissue remodeling to develop a pipeline of proprietary therapeutics. Our client’s first drug candidate is in development for the improvement of blood flow following vascular surgery procedures. With a strong, experienced management team, and close working relationships with external vendors, this is a great opportunity for the right candidate to grow and excel in a leading company. Position Location Director of Pre-Clinical Development Waltham, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop non-clinical study strategies for products and indications 2) Plan and supervise all contracted non-clinical development studies including in vitro, ex vivo and in vivo studies 3) Conduct pharmacokinetic, pharmacodynamic, toxicology, safety pharmacology and immunogenicity studies including related bio-analytical assay development 4) Select contract research organizations 5) Negotiate budgets and schedules 6) Review and approve protocols and study reports 7) Attend dosing as appropriate 8) Prepare regulatory submissions (pre-IND packages, INDs, NDAs, etc.) 9) Interact with regulatory agencies and corporate partners in the US and ROW 10) Provide inputs into designing, execution and reporting of pharmacology studies conducted at the company's laboratory in Kansas City as well as Kansas University Medical Center Requirements 1) BA or MS in a scientific field (Ph. D. or DVM a plus) 2) Experience in cardiovascular models 3) In-depth knowledge of drug development process 4) Organized with good attention to details 5) Ability to work independently 6) Ability to travel to CRO and partner site locations (including those outside the US)