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Job #03046

About our client Our client is a rapidly growing biotech company headquartered in Minnesota that is focused on the development and commercialization of therapeutics for oncology indications. The company has marketed products to support ongoing development, an experienced management team and board and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate. Position Location Pharmacologist/Toxicologist Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee safety pharmacology, pharmacokinetic and toxicology (all phases) 2) Study performance to support drug development (CRO selection, site audits, protocol design, study management, budget supervision and report writing) 3) Coordinate interpretation of safety pharmacology, pharmacokinetic and toxicology study results from legacy and new studies 4) Prepare summary documents describing results of studies 5) Write/review/manage safety pharmacology, pharmacokinetic and toxicology sections for IND/annual report/ BLA regulatory submissions and associated documents such as Investigator brochures, etc. 6) Provide support to Clinical, Regulatory Affairs, Legal and Marketing to coordinate pharmacology and toxicology activities related to company goals and objectives 7) Represent the company to regulatory authorities (e.g., FDA) on issues related to safety pharmacology, pharmacokinetics and toxicology 8) Provide support to Clinical Department, related to literature searches and exploration of potential new indications, etc. Requirements 1) Ph. D. in Pharmacology or Toxicology or equivalent (with PK modeling experience) 2) Minimum 5 years of experience as a Pharmacologist/Toxicologist in biotech and/or pharmaceutical industry 3) Recent experience in safety pharmacology, pharmacokinetics and toxicology 4) Experience in study management/project management 5) Knowledge of safety pharmacology, pharmacokinetics and toxicology 6) Excellent communication skills (oral and written) 7) Good organizational and interpersonal skills