Senior Project Scientist, Clinical Development

The Senior Project Scientist of Clinical Development is responsible for leading and executing pre-approval clinical development studies and activities. This person will be responsible for strategic planning, organization, and execution of studies required for INAD/NADA and JINAD/ANADA approvals in livestock. In addition, this person will contribute to FDA/CVM regulatory compliance and negotiations for new livestock product approval.

EDUCATION & EXPERIENCE:

MS, PhD or DVM in animal sciences, veterinary medicine or related field. An advanced degree desirable. Must have clinical experience with livestock (ruminants, swine and/or poultry) Must have 5+ years of experience of executing GxP clinical activities within the animal health industry Experienced at developing development timelines and budgets is desirable Regulatory Affairs experience with FDA/CVM desirable

TECHNICAL SKILLS REQUIREMENTS

Advanced understanding of FDA/CVM requirements for pharmaceutical development in livestock. Experience in designing and executing effectiveness, safety (target animal and human food safety), and bioequivalence studies. Demonstrated proficiency writing protocols and study reports for submission to FDA/CVM. Experience in working with Contract Research Organizations (CRO) to execute clinical studies. Knowledge and ability to analyze complex data and make good technical and business decisions based on this analysis. Ability and experience at leading and managing multiple projects simultaneously. Proficiency at acting strategically to align with technical and business needs. Ability to work effectively and communicate effectively with departments outside R&D and regulatory such as commercial and quality. Excellent verbal and written communication skills. Ability and experience delivering project updates to senior leadership.

PHYSICAL REQUIREMENTS:

Ability to safely and effectively perform the essential job functions consistent with the ADA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Must be able to drive an automobile. Travel will be required (up to 50%)

POSITION RESPONSIBILITIES:

Assumes leadership of clinical activities for various pharmaceutical projects across all livestock species. Responsible for generation and maintenance of project development plans, timeline, and budget. Ensure all project activities are compliant with FDA/CVM regulations. Design clinical studies, draft protocols, execute studies per regulatory requirements (GCP, GLP), coordinate analytical and statistical analyses, draft final study reports, and prepare data and results for submission to FDA/CVM that are compliant with regulatory agency expectations. Effectively utilize internal resources to deliver project milestones and timelines within established budget. Manage study activities conducted at contract research organizations. Engages directly with FDA/CVM on behalf of the company as needed. Collaborate with internal and external partners to ensure all analytical requirements (e.g. feed and plasma assay methods) are met for clinical studies. Works closely with project teams to develop strategic plans for future development projects. Work across the organization to identify and evaluate new product and business development opportunities. Establishes and develops relationships with external parties that may enhance our collaborations and partnerships. #J-18808-Ljbffr Huvepharma