Manager – Pre-Clinical Development

The incumbent will formulate pre-clinical (target animal safety, toxicology and pharmacokinetic) development plans for new products in development and will work collaboratively within and across project teams to adhere to time schedules and meet critical deadlines. Will design and write protocols for toxicology and target animal safety studies to gain information that will lead to regulatory approval of product.  Will initiate and monitor studies according to current federal regulations and company policies. Will analyze and interpret results and author study reports.  Will prepare data for submission to regulatory agencies and present data to regulatory authorities and/or at scientific meetings. Will coordinate and manage the pre-clinical group. Will provide an environment for personnel development. Will coach and develop personnel within the department. Will propose solutions or studies, including classic and innovative approaches, to address US and/or international product issues. Incumbent will participate in US and international product development teams as an internal expert in regulatory toxicology to provide guidance and advice on scientific issues and strategy in general toxicology to other scientists and regulatory personnel in the registration/approval of new products and in the defense of commercial products.

Other responsibilities include to participate in meetings with regulatory authorities to present and explain the position of our client company with respect to study requirements or concerns associated with the toxicology or safety of specific products. Establish partnership-based working relationships with scientific experts within regulatory authorities and facilitate the scientific and regulatory review process for our client’s products.  Incumbent will contribute to the risk assessment process by providing input to product safety managers/risk assessors on hazard identification, dose-response interpretation, use of mechanistic data and interpretation of toxicology profiles integrating information from other disciplines into the overall toxicological assessment. Incumbent will ensure Quality Assurance/Regulatory compliance and participate and/or lead administrative and procedural activities such as development of new Standard Operating Procedures.

Qualifications include PhD with board certification in toxicology or an advanced degree (MS or PhD) in addition to a DVM is desirable and should be in toxicology or a related field of pharmacology, pathology, etc.  Five or more years of experience in product development.

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